ISO 4802-2:2016

Glassware — Hydrolytic resistance of the interior surfaces of glass containers — Part 2: Determination by flame spectrometry and classification

ISO 4802-2:2016 specifies: a) methods 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 determining the amount of sodium and other alkali metal or alkaline earth oxides in the extraction solution using flame atomic emission or absorption spectrometry (flame spectrometry); b) a classification of glass containers according to the hydrolytic resistance of the interior surfaces determined by the methods specified in ISO 4802-2:2016. The test method specified in ISO 4802-2:2016 might not be applicable to containers whose surfaces have been treated with silicon (e.g. containers that are ready for direct filling).

Verrerie — Résistance hydrolytique des surfaces internes des récipients en verre — Partie 2: Détermination par spectrométrie de flamme et classification

Steklovina - Hidrolitska odpornost notranjih površin steklenih posod - 2. del: Določanje s plamensko spektrometrijo in klasifikacija

Ta del standarda ISO 4802 določa:
a) metodo za določanje hidrolitske odpornosti notranjih površin steklenih posod, ki so izpostavljene vodi s temperaturo 121 °C ± 1 °C za 60 minut ± 1 minuta. Odpornost se meri z določanjem količine natrija in drugih alkalnih ali zemeljsko alkalnih kovin v ekstrakcijski raztopini z uporabo plamenske atomske emisijske ali absorpcijske spektrometrije);
b) klasifikacijo steklenih posod glede na hidrolitsko odpornost notranjih površin, ki je določena z metodami, opredeljenimi v tem delu standarda ISO 4802.
Preskusne metode, opredeljena v tem delu standarda ISO 4802, morda ne bo mogoče uporabiti za vsebnike s površinami, ki so bile obdelane s silikonom (npr. vsebniki, ki so pripravljeni za neposredno polnjenje).

General Information

• Status: Withdrawn
• Publication Date: 12-Jun-2016
• 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/WG 2 - Rigid container systems and related accessories for parenterals and injectables
• Current Stage: 9599 - Withdrawal of International Standard
• Completion Date: 04-Dec-2023
• Ref Project: SIST ISO 4802-2:2018 - Glassware -- Hydrolytic resistance of the interior surfaces of glass containers -- Part 2: Determination by flame spectrometry and classification

Relations

• Revised: ISO 4802-2:2023 - Glassware — Hydrolytic resistance of the interior surfaces of glass containers — Part 2: Determination by flame spectrometry and classification
• Effective Date: 06-Jun-2022
• Revises: ISO 4802-2:2010 - Glassware — Hydrolytic resistance of the interior surfaces of glass containers — Part 2: Determination by flame spectrometry and classification
• Effective Date: 01-Nov-2014

Standards Content (Sample)

SLOVENSKI STANDARD
SIST ISO 4802-2:2018
01-september-2018
6WHNORYLQD+LGUROLWVNDRGSRUQRVWQRWUDQMLKSRYUãLQVWHNOHQLKSRVRGGHO
'RORþDQMHVSODPHQVNRVSHNWURPHWULMRLQNODVLILNDFLMD
Glassware -- Hydrolytic resistance of the interior surfaces of glass containers -- Part 2:
Determination by flame spectrometry and classification
Verrerie -- Résistance hydrolytique des surfaces internes des récipients en verre -- Partie
2: Détermination par spectrométrie de flamme et classification
Ta slovenski standard je istoveten z: ISO 4802-2:2016
ICS:
71.040.20 Laboratorijska posoda in Laboratory ware and related
aparati apparatus
SIST ISO 4802-2:2018 en
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.

---------------------- Page: 1 ----------------------

SIST ISO 4802-2:2018

---------------------- Page: 2 ----------------------

SIST ISO 4802-2:2018
INTERNATIONAL ISO
STANDARD 4802-2
Third edition
2016-06-15
Glassware — Hydrolytic resistance
of the interior surfaces of glass
containers —
Part 2:
Determination by flame spectrometry
and classification
Verrerie — Résistance hydrolytique des surfaces internes des
récipients en verre —
Partie 2: Détermination par spectrométrie de flamme et classification
Reference number
ISO 4802-2:2016(E)
©
ISO 2016

---------------------- Page: 3 ----------------------

SIST ISO 4802-2:2018
ISO 4802-2:2016(E)

COPYRIGHT PROTECTED DOCUMENT
© ISO 2016, Published in Switzerland
All rights reserved. Unless otherwise specified, 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
Ch. de Blandonnet 8 • CP 401
CH-1214 Vernier, Geneva, Switzerland
Tel. [phone]
Fax [phone]
[e-mail]
www.iso.org
ii © ISO 2016 – All rights reserved

---------------------- Page: 4 ----------------------

SIST ISO 4802-2:2018
ISO 4802-2:2016(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 . 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-bottom
...

INTERNATIONAL ISO
STANDARD 4802-2
Third edition
2016-06-15
Glassware — Hydrolytic resistance
of the interior surfaces of glass
containers —
Part 2:
Determination by flame spectrometry
and classification
Verrerie — Résistance hydrolytique des surfaces internes des
récipients en verre —
Partie 2: Détermination par spectrométrie de flamme et classification
Reference number
ISO 4802-2:2016(E)
©
ISO 2016

---------------------- Page: 1 ----------------------
ISO 4802-2:2016(E)

COPYRIGHT PROTECTED DOCUMENT
© ISO 2016, Published in Switzerland
All rights reserved. Unless otherwise specified, 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
Ch. de Blandonnet 8 • CP 401
CH-1214 Vernier, Geneva, Switzerland
Tel. [phone]
Fax [phone]
[e-mail]
www.iso.org
ii © ISO 2016 – All rights reserved

---------------------- Page: 2 ----------------------
ISO 4802-2:2016(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 . 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. 8
8.1 General .
...

SLOVENSKI STANDARD
oSIST ISO 4802-2:2018
01-julij-2018
6WHNORYLQD+LGUROLWVNDRGSRUQRVWQRWUDQMLKSRYUãLQVWHNOHQLKSRVRGGHO
'RORþDQMHVSODPHQVNRVSHNWURPHWULMRLQNODVLILNDFLMD
Glassware -- Hydrolytic resistance of the interior surfaces of glass containers -- Part 2:
Determination by flame spectrometry and classification
Verrerie -- Résistance hydrolytique des surfaces internes des récipients en verre -- Partie
2: Détermination par spectrométrie de flamme et classification
Ta slovenski standard je istoveten z: ISO 4802-2:2016
ICS:
71.040.20 Laboratorijska posoda in Laboratory ware and related
aparati apparatus
oSIST ISO 4802-2:2018 en
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.

---------------------- Page: 1 ----------------------
oSIST ISO 4802-2:2018

---------------------- Page: 2 ----------------------
oSIST ISO 4802-2:2018
INTERNATIONAL ISO
STANDARD 4802-2
Third edition
2016-06-15
Glassware — Hydrolytic resistance
of the interior surfaces of glass
containers —
Part 2:
Determination by flame spectrometry
and classification
Verrerie — Résistance hydrolytique des surfaces internes des
récipients en verre —
Partie 2: Détermination par spectrométrie de flamme et classification
Reference number
ISO 4802-2:2016(E)
©
ISO 2016

---------------------- Page: 3 ----------------------
oSIST ISO 4802-2:2018
ISO 4802-2:2016(E)

COPYRIGHT PROTECTED DOCUMENT
© ISO 2016, Published in Switzerland
All rights reserved. Unless otherwise specified, 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
Ch. de Blandonnet 8 • CP 401
CH-1214 Vernier, Geneva, Switzerland
Tel. [phone]
Fax [phone]
[e-mail]
www.iso.org
ii © ISO 2016 – All rights reserved

---------------------- Page: 4 ----------------------
oSIST ISO 4802-2:2018
ISO 4802-2:2016(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 . 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 con
...