ISO 10993-7-2026 Biological evaluation of medicaldevices-Part 7Ethylene oxide sterilizationresiduals

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Biological evaluation of medical

devices —

Part 7:

Ethylene oxide sterilization

residuals

Évaluation biologique des dispositifs médicaux —

Partie 7: Résidus de stérilisation à l'oxyde d'éthylène

International

Standard

ISO 10993-7

Third edition

2026-04

Reference number

ISO 10993-7:2026(en) © ISO 2026

(103.27.9.24) VALID UPTO 3/20/2027 11:59:00 PM

ISO 10993-7:2026(en)

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(103.27.9.24) VALID UPTO 3/20/2027 11:59:00 PM

ISO 10993-7:2026(en)

Foreword ....................................................................................................................................................................................................................................................iv

Introduction .............................................................................................................................................................................................................................................v

1 Scope ............................................................................................................................................................................................................................................. 1

2 Normative references ................................................................................................................................................................................................. 1

  ................................................................................................................................................................................................ 1

4 Requirements ...................................................................................................................................................................................................................... 5

  ........................................................................................................................................... ............................................................................. 5

  ...........................................................................................................................................................................6

  .................................................................................................................................................................................................. 6

  .....................................................................................................................................................................................................6

  .......................................................................................................................................................8

  .................................................................................................................................................9

  ................................................................................................................................................9

  .........................................................................................................................................................................11

  ............................................................................................................................................................ 12

  ................................................................................................................................... 12

  .......................................................................................................................................................................................... 12

  .......................................................................................................................................................... 12

  ........................................................................................................................................................................ 12

  .................................................................................................................................................................... 13

  ..................................................................................................................................................................... 13

  ............................................................................................................................................................... 13

5 Product release .............................................................................................................................................................................................................. 13

  ......... ........................................................................................................................................................................................................... 13

  ........................................................................................................................................................................14

  .........................................................................................14

  ......................................................................14

6 Adoption of products into established aeration family ......................................................................................................15

7 Change evaluation ....................................................................................................................................................................................................... 15

Annex A  Guidance for the application of this document for the determination of

EO and ECH residuals in medical devices ........................................................................................................................................... 16

Annex B  ......................................................................................................... 27

Annex C  Rationale for the provisions of this document ....................................................................................30

Annex D  Establishment of allowable limits for EO .................................................................................................. 38

Annex E  Establishment of allowable limits for ECH ............................................................................................... 56

Annex F  Ethylene glycol........................................................................................................................................................................66

Annex G  Evaluation of gas chromatograms ........................................................................................................................ 70

Annex H  Gas chromatographic determination for EO and ECH ................................................................. 74

Annex I  Preparation of EO and ECH standards ...........................................................................................................78

Annex J  Ethylene oxide and ethylene chlorohydrin residual measuring methods ..............82

Annex K  Examples of product release methods .........................................................................................................90

Bibliography ...................................................................................................................................................................................................................................... 109

iii

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标签： #ISO # 10993 #2026

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Biologicalevaluationofmedicaldevices—Part7:EthyleneoxidesterilizationresidualsÉvaluationbiologiquedesdispositifsmédicaux—Partie7:Résidusdestérilisationàl'oxyded'éthylèneInternationalStandardISO10993-7Thirdedition2026-04ReferencenumberISO10993-7:2026(en)©ISO2026(103.27.9.24)VALIDUPTO3/20/202711:59:00...

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ISO 10993-7-2026 Biological evaluation of medicaldevices-Part 7Ethylene oxide sterilizationresiduals

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