Sterilization of healthcare products — Microbiological methods— Guidance on conducting bioburden determinations and tests of sterility for biologics and tissue-based products

1.1.1 This document provides guidance for bioburden testing and tests of sterility for biologics and tissue-based products, where this testing is in relation to product sterilization. NOTE This document is intended to be used in conjunction with ISO 11737-1 and ISO 11737-2. 1.1.2 Guidance in this document can be applicable to biologics and tissue-based products that are not sterile but are microbiologically controlled.

Stérilisation des produits de santé — Méthodes microbiologiques — Recommandations pour la réalisation de déterminations de la charge biologique et de contrôles de stérilité des produits biologiques et des produits à base de tissus

General Information

Status
Published
Publication Date
18-Mar-2021
Current Stage
9020 - International Standard under periodical review
Start Date
15-Jan-2024
Completion Date
15-Jan-2024
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ISO/TS 22456:2021 - Sterilization of healthcare products -- Microbiological methods— Guidance on conducting bioburden determinations and tests of sterility for biologics and tissue-based products
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ISO/PRF TS 22456:Version 22-jan-2021 - Sterilization of healthcare products -- Microbiological Methods— Guidance on conducting bioburden determinations and tests of sterility for tissue-based products
English language
13 pages
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Standards Content (Sample)

TECHNICAL ISO/TS
SPECIFICATION 22456
First edition
2021-03
Sterilization of healthcare products —
Microbiological methods—
Guidance on conducting bioburden
determinations and tests of sterility
for biologics and tissue-based
products
Reference number
ISO/TS 22456:2021(E)
©
ISO 2021

---------------------- Page: 1 ----------------------
ISO/TS 22456:2021(E)

COPYRIGHT PROTECTED DOCUMENT
© ISO 2021
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
Email: copyright@iso.org
Website: www.iso.org
Published in Switzerland
ii © ISO 2021 – All rights reserved

---------------------- Page: 2 ----------------------
ISO/TS 22456:2021(E)

Contents Page
Foreword .iv
Introduction .v
1 Scope . 1
1.1 Inclusions . 1
1.2 Exclusions . 1
2 Normative references . 1
3 Terms and definitions . 2
4 Definition and maintenance of product families . 3
5 Selection and testing of product for bioburden and tests of sterility .3
5.1 General . 3
5.2 Nature of product . 4
5.3 Sample Item Portion (SIP) . 4
5.4 Sampling conditions . 4
5.4.1 General. 4
5.4.2 Considerations for human tissue donor batches in sterilization . 4
5.4.3 Use of multiple batches . 5
5.4.4 Considerations for packaging . 5
5.5 Microbiological testing . 5
5.5.1 Bioburden test considerations for biologics/tissues. 5
5.5.2 Test of sterility considerations for biologics/tissues . 8
5.5.3 Verification of microbiological methods .
...

TECHNICAL ISO/TS
SPECIFICATION 22456
First edition
Sterilization of healthcare products —
Microbiological Methods—
Guidance on conducting bioburden
determinations and tests of sterility
for tissue-based products
PROOF/ÉPREUVE
Reference number
ISO/TS 22456:2021(E)
©
ISO 2021

---------------------- Page: 1 ----------------------
ISO/TS 22456:2021(E)

COPYRIGHT PROTECTED DOCUMENT
© ISO 2021
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
Email: copyright@iso.org
Website: www.iso.org
Published in Switzerland
ii PROOF/ÉPREUVE © ISO 2021 – All rights reserved

---------------------- Page: 2 ----------------------
ISO/TS 22456:2021(E)

Contents Page
Foreword .iv
Introduction .v
1 Scope . 1
1.1 Inclusions . 1
1.2 Exclusions . 1
2 Normative references . 1
3 Terms and definitions . 2
4 Definition and maintenance of product families . 3
5 Selection and testing of product for bioburden and tests of sterility .3
5.1 General . 3
5.2 Nature of product . 4
5.3 Sample Item Portion (SIP) . 4
5.4 Sampling conditions . 4
5.4.1 General. 4
5.4.2 Considerations for human tissue donor batches in sterilization . 4
5.4.3 Use of multiple batches . 5
5.4.4 Considerations for packaging . 5
5.5 Microbiological testing . 5
5.5.1 Bioburden test considerations for biologics/tissues. 5
5.5.2 Test of sterility considerations for biologics/tissues . 8
5.5.3 Verification of microbiological methods .
...

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