drafts in document despatch advice wide …371-380)_12022015.pdf · part of iso 8362 will allow...

DRAFTS IN

WIDE CIRCULATION

TECHNICAL COMMITTEE: MHD 10

ADDRESSED TO:

1. All members of Medical Laboratory Instruments Sectional Committee, MHD 10 2. All Members of Medical Equipment and Hospital Planning Division Council (MHDC)

3. All others interested

Dear Madam/Sir(s),

Please find enclosed the following documents:

DOC NO: MHD 10(371)/ ISO 8362-1:2009

TITLE : Injection containers and accessories- Part1 : Injection vials made of glass tubing

DOC NO: MHD 10(372)/ISO 8362-4:2011

TITLE : : Injection containers and accessories- Part 4: Injection vials made of moulded glass

DOC NO: MHD 10(373)/ISO 9187-1:2010

TITLE : Injection equipment for medical use- Part1 : Ampoules for injectables

DOC NO: MHD 10(374)/ISO 6710:1995 TITLE : Single-use containers for venous blood specimen collection

DOC NO: MHD 10(375)/ISO 8536-1:2011 TITLE : Infusion equipment for medical use- Part1 : Infusion glass bottles

DOC NO: MHD 10(376)/ISO 11040-1:1992 TITLE : Prefilled syringes- Part1: Glass cylinders for dental local anesthetic cartridges

DOC NO: MHD 10(377)/ISO 11040-2: 2011 TITLE : Prefilled syringes - Part 2: Plunger stoppers for dental local anesthetic cartridges

DOC NO: MHD 10(378)/ISO 11040-3:2012 TITLE : Prefilled syringes - Part 3: Seals for dental local anesthetic cartridges

DOC NO: MHD 10(379)/ISO 11040-4:2007 TITLE : Prefilled syringes - Part 4: Glass barrels for injectables

DOC NO: MHD 10(380)/ISO 11040-5:2012 TITLE : Prefilled syringes - Part 5: Plunger stoppers for injectables

DOCUMENT DESPATCH ADVICE

Ref Date

MHD 10/ T-

2,3,41,33,43,44,45,46,47,48 10/02/2015

Kindly examine the draft standard and forward your views stating any difficulties, which you are likely to

experience in your business or profession, if these are finally adopted as National Standard.

Last date for comments: 15/05/2015

Comments if any, may please be made in the format indicated and mailed to the undersigned at the

above address. In case no comments are received or comments received are of editorial nature, you will

kindly permit us to presume your approval for the above document as finalized. However, in case

comments of technical nature are received then it may be finalized either in consultation with the

Chairman, Sectional Committee or referred to the Sectional committee for further necessary action if so

desired by the Chairman, Sectional Committee.

Thanking you,

Yours sincerely,

(S. Kishore Kumar)

Scientist ‘F’ & Head (MHD) Bureau of Indian Standards

9, B. S. Zafar Marg

New Delhi - 110002

Encl: As above Email:1) [email protected]

2) [email protected]

Telefax: 011-23230910

mailto:[email protected]

FORMAT FOR SENDING COMMENTS ON BIS DOCUMENTS

(Please use A4 size sheet of paper only and type within fields indicated. Comments on each

clauses/sub-clauses/table/fig. etc be started on a fresh box. Information in Column 4 should

include reasons for the comments and suggestions for modified wording of the clauses when the

existing text is found not acceptable. Adherence to this format facilitates Secretariat’s work)

DOC NO: MHD 10 (371)/ISO 8362-1:2009

TITLE : Injection containers and accessories- Part1: Injection vials made of glass tubing

LAST DATE OF COMMENTS: 15/05/2015

NAME OF THE COMMENTATOR/ORGANIZATION:

_____________________________________________________________________

Sl.

No.

Clause/Sub-

clause/

para/table/fig.

No. commented

Commentator/

Organization/

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Justification Proposed

change

Draft for Comments only Doc No: MHD 10 (371)

ISO 8362-1:2009

BUREAU OF INDIAN STANDARDS

(Not to be reproduced without permission of BIS or used as standard)

Draft Indian Standard

Injection containers and accessories- Part1: Injection vials made of glass tubing

(first revision)

Last date of receipt of comments is 15/05/2015

Medical Laboratory Instruments Sectional Committee, MHD 10

NATIONAL FOREWORD

(Formal clause of adoption will be added later)

This draft Indian Standard is identical with ISO 8362-1’ Injection containers and accessories- Part1:

Injection vials made of glass tubing’ issued by the International Organization for Standardization.

This standard was first published in 2003 as IS 8362-1 based on ISO 8362-1: 2003 which has been

revised in 2009. This revision is being taken to align it with the latest international practices.

The purpose of this part of ISO 8362 is to specify the dimensions, capacities, form and requirements of

glass vials intended for medical use. Containers made from glass tubing are considered to be suitable

for the packaging and storage of injectable preparations until they are administered for medicinal

purposes. Such containers may be made from different types of glass which can affect the chemical

resistance properties; e.g., those made from borosilicate glass will have a very high level of chemical

resistance whereas others made from soda-lime glass will have a lower, but adequate, chemical

resistance for the purpose for which they are intended. The chemical resistance of the internal surface

of containers made from soda-lime glass can be improved by means of a treatment during production

aimed at producing a chemical resistance equal to that of those made from borosilicate glass for single

use. This level of chemical resistance is maintained as long as the interior surface is not destroyed by

chemical attack, in which case it is reduced to that of untreated soda-lime glass.

Because containers may be made from different types of glass and because it is the chemical behaviour

of the internal surface which is important when they are filled with injectable preparations, it is

essential to specify test procedures by which this performance can be measured. The procedures

recommended in this part of ISO 8362 permit this performance, based on the hydrolytic resistance to be

measured and, from the result of measurement, it is possible to classify containers into their correct

category. The procedure also allows containers to be tested and to determine, after an intermediate

stage, whether the hydrolytic resistance is produced by the composition of the glass as a material or by

a treatment of the internal surface.

The text of ISO standard has been approved as suitable for publication as Indian Standard without

deviations. Certain conventions are, however, not identical to those used in the Indian Standards.

Attention is particularly drawn to the following:

a) Wherever the words ‘International Standard’ appear referring to this standard, they should be read as ‘Indian Standard’.

b) Comma (,) has been used as a decimal marker while in Indian Standards, the

current practice is to use a point (.) as the decimal marker.

In this adopted standard, reference appears to certain International Standards for which Indian

Standards also exist. The corresponding Indian Standards which are to be substituted in their places are

listed below along with their degree of equivalence for the editions indicated:

International Standards Corresponding Indian Standards Degree of

Equivalence

ISO 719, Glass — Hydrolytic

resistance of glass grains at 98

°C — Method of test and

classification

IS 2303 (Part 1/Sec 1) : 2012 Grading

Glass Part 1 Method Of Test And

Classification Section 1 Hydrolytic

Resistance of Glass Grains at 98°C

( Second Revision )

Identical


resistance of glass grains at

121 °C — Method of test and

classification





( Second Revision )

Identical

ISO 4802-1, Glassware —

Hydrolytic resistance of the

interior surfaces of glass

containers — Part 1:

Determination by titration

method and classification

IS 2303 ( Part 2 ) : 1994 Grading Glass

For Alkalinity Part 2 Hydrolytic

Resistance of Glass Containers ( First

Revision)

Technical

Equivalent

The technical committee responsible for the preparation of this standard has reviewed the provisions of

the following International Standards referred in this adopted standard and has decided that they are

acceptable for use in conjunction with this standard:

International Standard/ Title

Other publications

ISO 1101 Geometrical Product Specifications (GPS) — Geometrical

tolerancing — Tolerances of form, orientation, location and run-out

ISO 4802-2 Glassware — Hydrolytic resistance of the interior surfaces of glass

containers — Part 2: Determination by flame spectrometry and

classification

For the purpose of deciding whether a particular requirement of this standard is complied with, the final

value, observed or calculated, expressing the result of a test or analysis, shall be rounded off in

accordance with IS 2:1960 ‘Rules for rounding off numerical values (revised)’. The number of significant places retained in the rounded off value should be same as that of the specified value in this

standard.

The technical content of the document is not available on website. For details, please contact:

Head

Medical Equipment and Hospital Planning Department

Bureau of Indian Standards

9 Bahadur Shah Zafar Marg

New Delhi-110002

Email: [email protected]

[email protected]







DOC NO: MHD 10 (372)/ISO 8362-4:2011

TITLE : Injection containers and accessories- Part 4: Injection vials made of moulded glass



_____________________________________________________________________

Sl.

No.

Clause/Sub-

clause/

para/table/fig.

No. commented

Commentator/

Organization/

Abbreviation

Type of Comments

(General/Editorial/

Technical)


change


ISO 8362-4:2011




Injection containers and accessories- Part4: Injection vials made of moulded glass

(first revision)



NATIONAL FOREWORD


This draft Indian Standard is identical with ISO 8362-4:2011’ Injection containers and accessories- Part

4: Injection vials made of moulded glass’ issued by the International Organization for Standardization.

This standard was first published in 2003 as IS 1984-2 based on ISO 8362-4:1989 which has been


The purpose of this part of ISO 8362 is to specify the shape, dimensions and capacities of, and

performance requirements for, glass vials intended for medical use. Containers made from moulded

glass are considered to be suitable for the packaging and storage of injectable preparations until they

are administered for medicinal purposes. Such containers can be made from different types of glass,

which can affect the chemical resistance properties. For example, those made from borosilicate glass

will have a very high level of chemical resistance, whereas those made from soda-lime-silica glass will

have a lower chemical resistance but one that is adequate for the purpose for which the containers are

intended. The chemical resistance of the internal surface of containers made from soda-lime-silica glass

can be improved by a treatment during production to produce a chemical resistance equal to that of

containers made from borosilicate glass for single use. This level of chemical resistance will be

maintained as long as the interior surface is not destroyed by chemical attack, in which case it will be

reduced to that of untreated soda-lime-silica glass.

Because containers can be made from different types of glass and because it is the chemical behavior of

the internal surface that is important when they are filled with injectable preparations, it is essential to

specify test procedures by which this performance can be measured. The procedures specified in this

part of ISO 8362 will allow this performance based on the hydrolytic resistance to be measured and,

from the result of measurement, it is possible to classify containers into their correct category. The

procedures also allow containers to be tested and to determine whether the hydrolytic resistance is due

to the composition of the glass, or to a treatment of the internal surface










International Standards Corresponding Indian Standards Degree of Equivalence




classification





( Second Revision )

Identical




classification





( Second Revision )

Identical







IS 2303 ( Part 2 ) : 1994 Grading

Glass For Alkalinity Part 2 Hydrolytic


Revision)

Technical Equivalent

ISO 7458, Glass containers —

Internal pressure resistance —

Test methods

IS : 10516 - 1983 Methods of Test for

Internal Pressure Resistance of Glass

Containers



Thermal shock resistance and

thermal shock endurance — Test

methods

IS:11930- 1986 Methods of Thermal

Shock Tests for Glass Containers






Other publications

ISO 4802-2 Glassware — Hydrolytic resistance of the interior surfaces

of glass containers — Part 2: Determination by flame

spectrometry and classification




standard.


Head




New Delhi-110002


[email protected]







DOC NO: MHD 10 (373)/ISO 9187-1:2010

TITLE : Injection equipment for medical use - Part1: Ampoules for injectables



_____________________________________________________________________

Sl.

No.

Clause/Sub-

clause/

para/table/fig.

No. commented

Commentator/

Organization/

Abbreviation

Type of Comments

(General/Editorial/

Technical)


change


ISO 9187-1:2010




Injection equipment for medical use - Part1: Ampoules for injectables

(first revision)



NATIONAL FOREWORD


This draft Indian Standard is identical with ISO 9187-1:2010 ’ Injection equipment for medical use -

Part1: Ampoules for injectables’ issued by the International Organization for Standardization.

This standard was first published in 2004 as IS 15537 based on ISO 9187-1:2000 which has been


Ampoules are suitable packaging materials for storing pharmaceutical products until they are

administered to the patient. Owing to the direct contact between injectables and the primary container

over extended storage periods, possible interactions are to be avoided in order to guarantee patient

safety. Adequate means to achieve this objective include proper selection of primary packaging

materials, the choice of suitable package design and the availability of specific requirements and

methods for testing individual container systems.

In the past, four standardized forms of ampoule (forms A, B, C and D) have been in widespread use.

However, form A is no longer used in the pharmaceutical industry and consequently has not been

included in this part of ISO 9187. To avoid any confusion among manufacturers and users, it was

decided to retain the same designation letters (i.e. B, C and D) for the forms of ampoules in current use

and to disregard the letter A.














classification

IS 2303 (Part 1/Sec 2) : 2012

Grading Glass Part 1 Method Of Test

And Classification Section 2

Hydrolytic Resistance of Glass

Grains at 121°C

( Second Revision )

Identical





Determination by titration method

and classification

IS 2303 ( Part 2 ) : 1994 Grading

Glass For Alkalinity Part 2


Containers ( First Revision)


ISO 2859-1, Sampling procedures

for inspection by attributes — Part

1: Sampling schemes indexed by

acceptance quality limit (AQL) for

lot-by-lot inspection

IS 2500 (Part 1) :2000 Sampling

Procedure For Inspection By

Attributes Part 1 Sampling Schemes

Indexed By Acceptance Quality

Limit (AQL) For Lot-By-Lot

Inspection (Third Revision)

Identical

ISO 7500-1, Metallic materials —

Verification of static uniaxial

testing machines — Part 1:

Tension/compression testing

machines — Verification and

calibration of the force-measuring

system

IS 1828 (Part 1) :2005 Metallic

Materials — Verification of Static

Uniaxial Testing Machines Part 1

Tension/Compression Testing

Machines — Verification And

Calibration of the Force-Measuring

System ( Third Revision)

Identical





Other publications



classification




standard.


Head




New Delhi-110002


[email protected]







DOC NO: MHD 10 (374)/ISO 6710:1995

TITLE : Single-use containers for venous blood specimen collection



_____________________________________________________________________

Sl.

No.

Clause/Sub-

clause/

para/table/fig.

No. commented

Commentator/

Organization/

Abbreviation

Type of Comments

(General/Editorial/

Technical)


change


ISO 6710:1995




Single-use containers for venous blood specimen collection

(first revision)



NATIONAL FOREWORD


This draft Indian Standard is identical with ISO 6710:1995’ Single-use containers for venous blood

specimen collection’ issued by the International Organization for Standardization.

This standard was first published in 1984 as IS 10867 based on ISO 4822:1981 which has been revised

by ISO 6710:1995. This revision is being taken to align it with the latest international practices.










International Standards Corresponding Indian

Standards

Degree of

Equivalence

IS0 594-l : 1986, Conical fittings with

a 6 % (Luer) taper for syringes,

needles and certain other medical

equipment - Part I : General

requirements

IS:3234(Part1):l986

Specification for Conical

Fittings with a 6 Percent ( Luer

) Taper For Syringes, Needles

And Other Medical Equipment

Part 1 General Requirements

(Second Revision)

Identical





Other publications

ISO 3696: 1987 Water for analytical laboratory use -Specification and

test methods

IS0 7000: 1989 Graphical symbols for use on equipment - Index

and synopsis




standard.


Head




New Delhi-110002


[email protected]







DOC NO: MHD 10 (375)/ISO 8536-1:2011

TITLE : Infusion equipment for medical use - Part1 : Infusion glass bottles



_____________________________________________________________________

Sl.

No.

Clause/Sub-

clause/

para/table/fig.

No. commented

Commentator/

Organization/

Abbreviation

Type of Comments

(General/Editorial/

Technical)


change


ISO 8536-1:2011




Infusion equipment for medical use- Part1 : Infusion glass bottles



NATIONAL FOREWORD


This draft Indian Standard is identical with ISO 8536-1:2011 ’Infusion equipment for medical use-

Part1 : Infusion glass bottles’ issued by the International Organization for Standardization.

Infusion bottles are suitable primary packaging materials for the storage of infusion solutions until they

are administered to the patient. Due to the direct contact between infusion solution and the primary

container components and in view of the extended storage periods, it is essential to avoid possible

interactions in order to guarantee the patient's safety. Adequate means to achieve this goal include the

proper selection of the primary packaging materials, the choice of suitable package design and the

availability of specific criteria and methods for testing of individual container systems.












resistance of glass grains at 98 °C

— Method of test and

classification





( Second Revision )

Identical




classification





( Second Revision )

Identical







IS 2303 ( Part 2 ) : 1994 Grading Glass For

Alkalinity Part 2 Hydrolytic Resistance of

Glass Containers ( First Revision)



Internal pressure resistance —

Test methods

IS : 10516 - 1983 Methods of Test for

Internal Pressure Resistance of Glass

Containers



Thermal shock resistance and

thermal shock endurance — Test

methods

IS:11930- 1986 Methods of Thermal Shock

Tests for Glass Containers






Other publications



classification




standard.


Head




New Delhi-110002


[email protected]







DOC NO: MHD 10 (376)/ISO 11040-1:1992

TITLE : Prefilled Syringes- Part 1: Glass cylinders for dental local anesthetic cartridges



_____________________________________________________________________

Sl.

No.

Clause/Sub-

clause/

para/table/fig.

No. commented

Commentator/

Organization/

Abbreviation

Type of Comments

(General/Editorial/

Technical)


change


ISO 11040-1:1992




Prefilled Syringes- Part 1: Glass cylinders for dental local anesthetic cartridges



NATIONAL FOREWORD


This draft Indian Standard is identical with ISO 11040-1:1992 ’Prefilled Syringes- Part 1: Glass

cylinders for dental local anesthetic cartridges’ issued by the International Organization for Standardization.














classification





( Second Revision )

Identical







IS 2303 ( Part 2 ) : 1994 Grading

Glass For Alkalinity Part 2 Hydrolytic


Revision)






Other publications

ISO 4802-2: 1988 Glassware - Hydrolytic resistance of the interior surfaces of

glass Containers - Part 2: Determination by flame spectrometry and

classification




standard.


Head




New Delhi-110002


[email protected]







DOC NO: MHD 10 (377)/ISO 11040-2:2011

TITLE : Prefilled Syringes - Part 2: Plunger stoppers for dental local anesthetic cartridges



_____________________________________________________________________

Sl.

No.

Clause/Sub-

clause/

para/table/fig.

No. commented

Commentator/

Organization/

Abbreviation

Type of Comments

(General/Editorial/

Technical)


change


ISO 11040-2:2011




Prefilled Syringes - Part 2: Plunger stoppers for dental local anesthetic cartridges



NATIONAL FOREWORD


This draft Indian Standard is identical with ISO 11040-2:2011 Prefilled Syringes - Part 2: Plunger

stoppers for dental local anesthetic cartridges’ issued by the International Organization for Standardization.

Primary packaging components made of elastomeric materials are an integral part of medicinal

products. As such, the principles of current Good Manufacturing Practices (cGMP) are applicable to

the manufacturing of these components.











ISO 48 Rubber, vulcanized or

thermoplastic — Determination of

hardness (hardness between 10

IRHD and 100 IRHD)

IS 3400 (Part 2) : 2014 Methods of

Test for Vulcanized Rubber Part 2

Rubber, Vulcanized or

Thermoplastic — Determination of

Hardness (Hardness Between 10

IRHD and 100 IRHD) ( Fourth

Revision )

Identical

ISO 7619-1, Rubber, vulcanized or

thermoplastic —Determination of

indentation hardness — Part 1:

IS 3400 (Part 23): 2002 Methods of

Test for Vulcanized Rubbers Part

23: Rubber — Determination of

Identical with ISO

7619:1997 Rubber —

Determination of

Durometer method (Shore

hardness)

Indentation Hardness By Means of

Pocket Hardness Meters

indentation hardness by

means of pocket

hardness meters





Other publications

ISO 3302 (all parts) Rubber — Tolerances for products

ISO 8871-1 Elastomeric parts for parenterals and for devices for pharmaceutical use — Part

1: Extractables in aqueous autoclavates

ISO 8871-4 Elastomeric parts for parenterals and for devices for pharmaceutical use — Part

4: Biological requirements and test methods

ISO 11040-1 Prefilled syringes — Part 1: Glass cylinders for dental local anaesthetic cartridges

ISO 11040-3 Prefilled syringes — Part 3: Seals for dental local anaesthetic cartridges




standard.


Head




New Delhi-110002


[email protected]







DOC NO: MHD 10 (378)/ISO 11040-3:2012

TITLE : Prefilled Syringes - Part 3: Seals for dental local anesthetic cartridges



_____________________________________________________________________

Sl.

No.

Clause/Sub-

clause/

para/table/fig.

No. commented

Commentator/

Organization/

Abbreviation

Type of Comments

(General/Editorial/

Technical)


change


ISO 11040-3:2012




Prefilled Syringes - Part 3: Seals for dental local anesthetic cartridges



NATIONAL FOREWORD


This draft Indian Standard is identical with ISO 11040-3:2012 Prefilled Syringes - Part 3: Seals for

dental local anesthetic cartridges’ issued by the International Organization for Standardization.


products. Therefore, the principles of current good manufacturing practices (cGMP) apply to the

manufacturing of these components.




a) Wherever the words ‘International Standard’ appear referring to this standard,

they should be read as ‘Indian Standard’.







ISO 7619-1 Rubber, vulcanized or




hardness)






Identical with ISO

7619:1997 Rubber —

Determination of


means of pocket

hardness meters





Other publications

ISO 3302-1 Rubber — Tolerances for products — Part 1: Dimensional tolerances

ISO 7885:2010 Dentistry — Sterile dental injection needles for single use

ISO 8871-1 Elastomeric parts for parenterals and for devices for pharmaceutical use — Part 1:

Extractables in aqueous autoclavates

ISO 8871-4 Elastomeric parts for parenterals and for devices for pharmaceutical use — Part 4:

Biological requirements and test methods

ISO 8871-5:2005 Elastomeric parts for parenterals and for devices for pharmaceutical use — Part 5:

Functional requirements and testing

ISO 8872 Aluminium caps for transfusion, infusion and injection bottles — General requirements

and test methods

ISO 11040-1 Prefilled syringes — Part 1: Glass cylinders for dental local anaesthetic cartridges

ISO 11040-2 Prefilled syringes — Part 2: Plunger stoppers for dental local anaesthetic cartridges




standard.


Head




New Delhi-110002


[email protected]







DOC NO: MHD 10 (379)/ISO 11040-4:2007

TITLE : Prefilled Syringes - Part 4: Glass Barrels for injectables



_____________________________________________________________________

Sl.

No.

Clause/Sub-

clause/

para/table/fig.

No. commented

Commentator/

Organization/

Abbreviation

Type of Comments

(General/Editorial/

Technical)


change


ISO 11040-4:2007




Prefilled Syringes - Part 4: Glass Barrels for injectables



NATIONAL FOREWORD


This draft Indian Standard is identical with ISO 11040-4:2007 Prefilled Syringes - Part 4: Glass Barrels

for injectables’ issued by the International Organization for Standardization.

For the parenteral use of liquid pharmaceutical products, at present ampoules and injection vials are

mainly used. However, for the injection of the liquid pharmaceutical products contained in those vials,

a hypodermic syringe combined with the appropriate injection needle is also needed. This means the

liquid pharmaceutical product has to be transferred to the hypodermic syringe before its final use. This

procedure is not only time consuming, but also presents a great number of possibilities for

contamination.

To ensure safe use of a liquid pharmaceutical product, prefilled syringes for single use are already on

the market. Without doubt, such prefilled syringes permit immediate injection of the product contained

after relatively simple handling.

Based on diameter of the prefilled syringes, appropriate components, such as rubber plungers and

aluminium caps, can also be standardized. The producers of filling machines can apply this part of ISO

11040 to achieve a degree of standardization in the equipment of the machines.











IS0 594-l Conical fittings with a 6

% (Luer) taper for syringes, needles

and certain other medical

equipment - Part I : General

requirements

IS:3234(Part1):l986 Specification

for Conical Fittings with a 6

Percent ( Luer ) Taper For

Syringes, Needles And Other

Medical Equipment Part 1 General

Requirements (Second Revision)

Identical

ISO 594-2 Conical fittings with 6

% (Luer) taper for syringes, needles

and certain other medical

equipment —

Part 2: Lock fittings

IS 3234(Part2):1995 Conical

Fltttngs With a 6% (Luer) Taper

For Syringes, Needles and Certain

Other Medical Equipment Part 2

Lock Fittings

Identical


resistance of glass grains at 121 °C

— Method of test and classification

IS 2303 (Part 1/Sec 2) : 2012

Grading Glass Part 1 Method Of

Test And Classification Section 2


Grains at 121°C

( Second Revision )

Identical


Hydrolytic resistance of the interior

surfaces of glass containers — Part

1:Determination by titration method

and classification

IS 2303 ( Part 2 ) : 1994 Grading

Glass For Alkalinity Part 2


Containers ( First Revision)






Other publications

ISO 4802-2 Glassware — Hydrolytic resistance of the interior surfaces

of glass containers — Part 2: Determination by flame

spectrometry and classification




standard.


Head




New Delhi-110002


[email protected]







DOC NO: MHD 10 (380)/ISO 11040-5:2012

TITLE : Prefilled Syringes - Part 5: Plunger stoppers for injectables



_____________________________________________________________________

Sl.

No.

Clause/Sub-

clause/

para/table/fig.

No. commented

Commentator/

Organization/

Abbreviation

Type of Comments

(General/Editorial/

Technical)


change


ISO 11040-5:2012




Prefilled Syringes - Part 5: Plunger stoppers for injectables



NATIONAL FOREWORD


This draft Indian Standard is identical with ISO 11040-5:2012 'Prefilled Syringes - Part 5: Plunger

stoppers for injectables’ issued by the International Organization for Standardization.


products. Therefore, the principles of current good manufacturing practices (cGMP) apply to the

manufacturing of these components.











ISO 7619-1, Rubber, vulcanized or




hardness)






Identical with ISO

7619:1997 Rubber —

Determination of


means of pocket

hardness meters





Other publications

ISO 3302-1 Rubber — Tolerances for products — Part 1: Dimensional tolerances

ISO 8871‑1 Elastomeric parts for parenterals and for devices for pharmaceutical use — Part 1:

Extractables in aqueous autoclavates

ISO 8871‑4 Elastomeric parts for parenterals and for devices for pharmaceutical use — Part 4:

Biological requirements and test methods

ISO 11040‑4 Prefilled syringes — Part 4: Glass barrels for injectables




standard.


Head




New Delhi-110002


[email protected]


drafts in document despatch advice wide …371-380)_12022015.pdf · part of iso 8362 will allow...

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