YY/T 1464-2016 Replaced Industry standards-Medicine

YY/T 1464-2016 Sterilization of medical devices—Requirements for the development,validation and routine control of a low temperature steam and formaldehyde sterilization process for medical devices

Publish Date: 2016-01-26 Implement Date: 2017-01-01 For services related to genuine standard inquiry, procurement, translation, and other related services in China, please Contact Us

Basic Information

Standard Code: YY/T 1464-2016

Standard Type: Industry standards

Standard Status: Replaced

is_force_gb: no

CCS Name: Public medical equipment

ICS Name: Integrated disinfection and sterilization

Publish Date: 2016-01-26

Implement Date: 2017-01-01

Pages: 33 pages

Scope

1.1 Applicability
1.1.1 This standard specifies the requirements for the development, validation, and routine control of the low-temperature steam formaldehyde sterilization process for medical devices.
Note: Although the scope of this standard is limited to medical devices, the requirements specified and the guidance provided in it can be applied to other products and equipment.

Development Information

Word Count: 64 Thousand words Pages: 33 pages

Superseded by the following standards

YY/T 1464-2022 Sterilization of health care products—Low temperature steam and formaldehyde—Requirements for development,validation and routine control of a sterilization process for medical devices

Referenced Standards

GB 18281.5-2015 Sterilization of health care products—Biological indicator—Part 5:Biological indicators for low-temperature steam and formaldehyde sterilization processes ISO 11138-1 ISO 11140 ISO 11737-1 ISO 11737-2 ISO 13485 EN 4180:2003

Adopt standards

ISO 25424:2009

Related Standards

GB 18278-2000 Replaced

GB 18278-2000 Sterilization of health care products—Requirements for validation and routine control—Industrial moist heat sterilization

Publish Date: 2000-12-13

GB 18281.1-2000 Replaced

GB 18281.1-2000 Sterilization of health care products—Biological indicators—Part 1:General

Publish Date: 2000-12-13

GB 18281.2-2000 Replaced

GB 18281.2-2000 Sterilization of health care products—Biological indicators—Part 2:Biological indicators for ethylene oxide sterilization

Publish Date: 2000-12-13

GB 18281.3-2000 Replaced

GB 18281.3-2000 Sterilization of health care products—Biological indicators—Part 3:Biological indicators for moist heat sterilization

Publish Date: 2000-12-13

GB 18282.1-2000 Replaced

GB 18282.1-2000 Sterilization of health care products—Chemical indicators—Part 1:General requirements

Publish Date: 2000-12-13

YY/T 0567.2-2005 Replaced

YY/T 0567.2-2005 Aseptic processing of health care products—Part 2:filtration

Publish Date: 2005-04-05