YY/T 1464-2022Sterilization of healthcare products - Low temperature steam formaldehyde - Requirements for the development, validation and routine control of medical device sterilization processes (English PDF)
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Issued by
State Drug Administration
Level / Type
National · Recommended
Issue date
October 17, 2022
Implementation date
October 1, 2023
Scope
YY/T 1464-2022 (Sterilization of healthcare products - Low temperature steam formaldehyde - Requirements for the development, validation and routine control of medical device sterilization processes) is available as an English-translated PDF.
YY/T 1464-2022 — This standard specifies the requirements for the development, validation and routine control of the low temperature steam formaldehyde sterilization process for medical devices.
This standard applies to the sterilization process using mixed low-temperature steam formaldehyde as a sterilization factor under negative pressure conditions.
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Document preview — YY/T 1464-2022
National Standard of the People's Republic of China
- Classification
- C 47
- Replacing
- YY/T 1464-2016
Issued by: State Drug Administration
Contents
- What this standard covers1
- Document data2
What this standard covers
This standard specifies the requirements for the development, validation and routine control of the low temperature steam formaldehyde sterilization process for medical devices. This standard applies to the sterilization process using mixed low-temperature steam formaldehyde as a sterilization factor under negative pressure conditions. This standard does not apply to the requirements for the development, validation and routine control of spongiform encephalopathy (such as scrapie, bovine spongiform encephalopathy and Creutzfeldt-Jakob disease) pathogen inactivation process.
Document data
Chinese classification (CCS): C47.
Estimated length of the Chinese original: 39,323 words.
Supersedes the earlier edition YY/T 1464-2016.
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This preview omits tables, figures, formulas and parts of the technical clauses. The complete document — 26 pages — is available in the English PDF.
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YY/T 1464-2022
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