T/NAHIEM 111-2024 Active Group standards

T/NAHIEM 111-2024 Biological and medical industry transfer window technical specifications

Publish Date: 2024-04-15 Implement Date: 2024-04-15 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/NAHIEM 111-2024

Standard Type: Group standards

Standard Status: Active

is_force_gb: no

CCS Name: -

ICS Name: Integrated medical equipment

Publish Date: 2024-04-15

Implement Date: 2024-04-15

Pages: 30 pages

Scope

Main technical content: This technical specification is divided into ten chapters and twenty-five sections (excluding the appendix). It is applicable to the production, inspection, and verification of logistics transfer window equipment with cleanliness requirements in adjacent spaces in the biomedical and medical industries. It is used as a reference for various specific requirements, including transfer window classification, basic provisions, technical requirements, inspection methods, inspection rules, product marking, packaging, transportation, and storage. Particularly in the biomedical and medical industries, it specifically includes sub-industries such as biomedicine, bio-agriculture, bio-energy, bio-environmental protection, bio-industry, bio-experiments, and laboratory animals; the medical industry refers to a series of related industries related to human health and wellness, including hospitals, pharmaceuticals, medical devices, health management, and services. This technical specification only focuses on the logistics transfer window equipment process required in the biomedical and medical industries.

Development Information

Pages: 30 pages

Related Standards

GB/T 16886.11-1997 Replaced

GB/T 16886.11-1997 Biological evaluation of medical devices—Part 11:Tests for systemic toxicity

Publish Date: 1997-06-26

GB/T 16886.3-1997 Replaced

GB/T 16886.3-1997 Biological evaluation of medical devices—Part 3:Tests for genotoxicity, carcinogenicity and reproductive toxicity

Publish Date: 1997-06-26

GB/T 16886.6-1997 Replaced

GB/T 16886.6-1997 Biological evaluation of medical devices—Part 6:Tests for local effects after implantation

Publish Date: 1997-06-26

GB/T 16886.1-2001 Replaced

GB/T 16886.1-2001 Biological evaluation of medical devices—Part 1:Evaluation and testing

Publish Date: 2001-09-24

GB/T 16886.13-2001 Replaced

GB/T 16886.13-2001 Biological evaluation of medical devices—Part 13:Identification and quantification of degradation products from polymeric medical devices

Publish Date: 2001-09-24

GB/T 16886.7-2001 Replaced

GB/T 16886.7-2001 Biological evaluation of medical devices—Part 7:Ethylene oxide sterilization residuals

Publish Date: 2001-09-24