ISO 10993-7 (edition Second edition 2008-10-15 with Corrigendum 1 (2009) and Amendment 1 (2020)) is Biological evaluation of medical devices - Part 7: Ethylene oxide sterilization residuals.

Which markets recognize ISO 10993-7?

United States: recognized, Second edition 2008 with Corrigendum 1 (2009) and Amendment 1 (2020); United Kingdom: recognized, EN ISO 10993-7:2008 with corrigendum AC:2009; Japan: adopted, ISO 10993-7:2008, identical JIS version, national code JIS T 0993-7:2012; China: national equivalent, national code GB/T 16886.7-2015; Canada: recognized, Latest version (the list gives no edition or year).

Is the text of ISO 10993-7 free?

No. The text is sold by ISO. This page gives the code, title, edition and scope only.

Metric	Value	Period
Total Revenue	9999999999999	FY2099
Net Income	-8888888888	FY2099
Earnings Per Share	123.456789	FY2099
Gross Profit	7777777777	FY2099
Operating Income	6666666666	FY2099

Metric	Value	Period
Total Revenue	9999999999999	FY2099
Net Income	-8888888888	FY2099
Earnings Per Share	123.456789	FY2099
Gross Profit	7777777777	FY2099
Operating Income	6666666666	FY2099

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ISO 10993-7 (Second edition 2008-10-15 with Corrigendum 1 (2009) and Amendment 1 (2020))

Biological evaluation of medical devices - Part 7: Ethylene oxide sterilization residuals

ISOInternational standardSterilizationMedical devicesHigh confidenceLast verified October 4, 2026

The text of this standard is sold by ISO and is not reproduced here. This page gives the code, edition, scope and what each market says about it.

Recognition by market

Whether the market recognizes, harmonizes or adopts this standard, and which edition it accepts

Market	Status	Edition accepted	National code	Details
United States	Recognized	Second edition 2008 with Corrigendum 1 (2009) and Amendment 1 (2020)	-	Recognition number 2-275. Voluntary: a declaration of conformity to a recognized standard can be used in a submission.
United Kingdom	Recognized	EN ISO 10993-7:2008 with corrigendum AC:2009	-	Recognition number List row 74. Voluntary: a device that conforms to a designated standard is treated as complying with the related essential requirement unless there are reasonable grounds to suspect that it does not.

National standards based on it

JIS T 0993-7Biological evaluation of medical devices - Part 7: Ethylene oxide sterilization residuals (JIS version)

Testing requirements that cite it

Open the market page and its pathway pages for the full requirement, protocol and report content

Not legal or regulatory advice. Check the current official rules before you act. Parts of the approvals data are official open data reused under open licences. Data sources.