T/WSJD 11-2020 Active Group standards

T/WSJD 11-2020 Guidelines for the performance testing and evaluation of medical sterilizers in healthcare institutions

Publish Date: 2020-12-16 Implement Date: 2021-01-01 For services related to genuine standard inquiry, procurement, translation, and other related services in China, please Contact Us

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Basic Information

Standard Code: T/WSJD 11-2020

Standard Type: Group standards

Standard Status: Active

is_force_gb: no

CCS Name: Public medical equipment

ICS Name: Integrated disinfection and sterilization

Publish Date: 2020-12-16

Implement Date: 2021-01-01

Scope

Main technical content: This document specifies the general requirements, testing content and requirements, as well as records and reports for the performance evaluation of medical sterilizers used in medical and health institutions. This document is applicable to the performance evaluation of newly installed medical sterilizers such as pressure steam sterilizers, ethylene oxide sterilizers, low-temperature steam formaldehyde sterilizers, hydrogen peroxide gas plasma low-temperature sterilizers, and dry heat sterilizers in all levels and types of medical and health institutions, as well as the re-calibration evaluation before restarting after relocation, major overhaul, or being idle for more than half a year. Note 1: The sterilization performance evaluation specified in this document is the most important requirement. Note 2: The sterilant used in ethylene oxide sterilizers is 100% ethylene oxide gas.

Development Information

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