ISO 4802-1:2023

Glassware — Hydrolytic resistance of the interior surfaces of glass containers — Part 1: Determination by titration method and classification

This document specifies: a) a method for determining the hydrolytic resistance of the interior surfaces of glass containers when subjected to attack by water at (121 ± 1) °C for (60 ± 1) min. The resistance is measured by titration of a known aliquot portion of the extraction solution produced with hydrochloric acid solution, in which case the resistance is inversely proportional to the volume of acid required; b) a classification of glass containers according to the hydrolytic resistance of the interior surfaces determined by the methods specified in this document.

Verrerie — Résistance hydrolytique des surfaces internes des récipients en verre — Partie 1: Détermination par analyse titrimétrique et classification

Le présent document spécifie: a) une méthode de détermination de la résistance hydrolytique des surfaces internes des récipients en verre lorsqu’ils sont soumis à l’attaque de l’eau à (121 ± 1) °C durant (60 ± 1) min. La résistance hydrolytique est mesurée par titrage d’une partie aliquote connue de la solution d’extraction obtenue avec une solution d’acide chlorhydrique; dans ce cas, la résistance hydrolytique est inversement proportionnelle au volume d’acide nécessaire au titrage; b) une classification des récipients en verre selon la résistance hydrolytique des surfaces internes déterminée par la méthode spécifiée dans le présent document.

General Information

• Status: Published
• Publication Date: 03-Dec-2023
• ICS: 71.040.20 - Laboratory ware and related apparatus
• Technical Committee: ISO/TC 76 - Transfusion, infusion and injection, and blood processing equipment for medical and pharmaceutical use
• Drafting Committee: ISO/TC 76 - Transfusion, infusion and injection, and blood processing equipment for medical and pharmaceutical use
• Current Stage: 6060 - International Standard published
• Start Date: 04-Dec-2023
• Due Date: 26-Nov-2024
• Completion Date: 04-Dec-2023

Relations

• Revises: ISO 4802-1:2016 - Glassware — Hydrolytic resistance of the interior surfaces of glass containers — Part 1: Determination by titration method and classification
• Effective Date: 06-Jun-2022

Standards Content (Sample)

INTERNATIONAL ISO
STANDARD 4802-1
Fourth edition
2023-12
Glassware — Hydrolytic resistance
of the interior surfaces of glass
containers —
Part 1:
Determination by titration method
and classification
Verrerie — Résistance hydrolytique des surfaces internes des
récipients en verre —
Partie 1: Détermination par analyse titrimétrique et classification
Reference number
ISO 4802-1:2023(E)
© ISO 2023

---------------------- Page: 1 ----------------------
ISO 4802-1:2023(E)
COPYRIGHT PROTECTED DOCUMENT
© ISO 2023
All rights reserved. Unless otherwise specified, or required in the context of its implementation, no part of this publication may
be reproduced or utilized otherwise in any form or by any means, electronic or mechanical, including photocopying, or posting on
the internet or an intranet, without prior written permission. Permission can be requested from either ISO at the address below
or ISO’s member body in the country of the requester.
ISO copyright office
CP 401 • Ch. de Blandonnet 8
CH-1214 Vernier, Geneva
Phone: [phone]
Email: [e-mail]
Website: www.iso.org
Published in Switzerland
ii
  © ISO 2023 – All rights reserved

---------------------- Page: 2 ----------------------
ISO 4802-1:2023(E)
Contents Page
Foreword .iv
Introduction .v
1 Scope . 1
2 Normative references . 1
3 Terms and definitions . 1
4 Principle . 4
5 Reagents . 4
6 Apparatus . 5
7 Sample preparation .6
7.1 Sample size . 6
7.2 Determination of the filling volume . 6
7.2.1 Flat-bottomed containers ≤20 mm outer flange diameter (except ampoules,
syringes and cartridges) . 6
7.2.2 Flat-bottomed containers >20 mm outer flange diameter. 7
7.2.3 Round-bottomed containers . 7
7.2.4 Lipped containers . 7
7.2.5 Ampoules. 7
7.2.6 Syringes and cartridges . 7
8 Procedure .
...

INTERNATIONAL ISO
STANDARD 4802-1
Fourth edition
Glassware — Hydrolytic resistance
of the interior surfaces of glass
containers —
Part 1:
Determination by titration method
and classification
Verrerie — Résistance hydrolytique des surfaces internes des
récipients en verre —
Partie 1: Détermination par analyse titrimétrique et classification
PROOF/ÉPREUVE
Reference number
ISO 4802-1:2023(E)
© ISO 2023

---------------------- Page: 1 ----------------------
ISO 4802-1:2023(E)
COPYRIGHT PROTECTED DOCUMENT
© ISO 2023
All rights reserved. Unless otherwise specified, or required in the context of its implementation, no part of this publication may
be reproduced or utilized otherwise in any form or by any means, electronic or mechanical, including photocopying, or posting on
the internet or an intranet, without prior written permission. Permission can be requested from either ISO at the address below
or ISO’s member body in the country of the requester.
ISO copyright office
CP 401 • Ch. de Blandonnet 8
CH-1214 Vernier, Geneva
Phone: [phone]
Email: [e-mail]
Website: www.iso.org
Published in Switzerland
ii
PROOF/ÉPREUVE © ISO 2023 – All rights reserved

---------------------- Page: 2 ----------------------
ISO 4802-1:2023(E)
Contents Page
Foreword .iv
Introduction .v
1 Scope . 1
2 Normative references . 1
3 Terms and definitions . 1
4 Principle . 4
5 Reagents . 4
6 Apparatus . 5
7 Sample preparation .6
7.1 Sample size . 6
7.2 Determination of the filling volume . 6
7.2.1 Flat-bottomed containers ≤20 mm outer flange diameter (except ampoules,
syringes and cartridges) . 6
7.2.2 Flat-bottomed containers >20 mm outer flange diameter. 7
7.2.3 Round-bottomed containers . 7
7.2.4 Lipped containers . 7
7.2.5 Ampoules. 7
7.2.6 Syringes and cartridges . 7
8 Procedure .
...

ISO /PRF 4802-1:2023(E)
ISO/TC 76
Secretariat: DIN
ISO/ TC 76
Date: 2023-08-0710-12
Glassware — Hydrolytic resistance of the interior surfaces of
glass containers —
Part 1:
Determination by titration method and classification
Verrerie — Résistance hydrolytique des surfaces internes des récipients en verre —
Partie 1: Détermination par analyse titrimétrique et classification
FDIS stage

---------------------- Page: 1 ----------------------
ISO/PRF 4802-1:2023(E)
© ISO 2023
All rights reserved. Unless otherwise specified, or required in the context of its implementation, no part of this
publication may be reproduced or utilized otherwise in any form or by any means, electronic or mechanical,
including photocopying, or posting on the internet or an intranet, without prior written permission. Permission can
be requested from either ISO at the address below or ISO’s member body in the country of the requester.
ISO copyright office
CP 401 • Ch. de Blandonnet 8
CH-1214 Vernier, Geneva
Phone: + 41 22 749 01 11
EmailE-mail: [e-mail]
Website: www.iso.orgwww.iso.org
Published in Switzerland
ii © ISO 2023 – All rights reserved
ii © ISO 2023 – All rights reserved

---------------------- Page: 2 ----------------------
ISO/PRF 4802-1:2023(E)
Contents
Foreword . v
Introduction .vi i
1 Scope . 1
2 Normative references . 1
3 Terms and definitions . 1
4 Principle . 4
5 Reagents . 5
6 Apparatus . 6
7 Sample preparation . 6
7.1 Sample size . 6
7.2 Determination of the filling volume . 7
7.2.1 Flat-bottomed containers ≤20 mm outer flange diameter (except ampoules, syringes and
cartridges) . 7
7.2.2 Flat-bottomed containers >20 mm outer flange diameter . 7
7.2.3 Round-bottomed containers . 7
7.2.4 Lipped containers . 8
7.2.5 Ampoules . 8
7.2.6 Syringes and cartridges . 8
8 Procedure . 9
8.1 General . 9
8.2 Cleaning of samples .
...