T/CIRA 13-2020 Active Group standards

T/CIRA 13-2020 Radiation-based preparation of medical hydrogels: Technical specifications

Publish Date: 2020-12-28 Implement Date: 2021-03-01 For services related to genuine standard inquiry, procurement, translation, and other related services in China, please Contact Us

Price: $ 20.00

Out of stock

Basic Information

Standard Code: T/CIRA 13-2020

Standard Type: Group standards

Standard Status: Active

is_force_gb: no

CCS Name: Medical devices

ICS Name: Other standards related to nuclear energy

Publish Date: 2020-12-28

Implement Date: 2021-03-01

Scope

Scope: This document specifies the technical requirements, test methods, irradiation processes, and quality control for medical hydrogels prepared by radiation methods. This document is applicable to medical hydrogels prepared by radiation methods. Main technical content: This part is based on the format requirements of GB/T 1.1-2020 "Guidelines for Standardization Work - Part 1: Structure and Drafting Rules for Standardization Documents", and combined with the characteristics of technical standards. It is divided into 10 chapters: scope, normative reference documents, terms and definitions, technical requirements, irradiation processes and quality control, inspection rules, marking, packaging, transportation, and storage. An appendix is also provided for commonly used monomer materials in the preparation of medical hydrogels by irradiation methods. 1. Technical requirements for the preparation of medical hydrogels by irradiation methods, including requirements for production equipment, production environment, and processing processes; ionizing radiation source requirements; sensory requirements and physicochemical requirements; biocompatibility requirements; stability of medical hydrogels, substance transfer characteristics, and kinetic characteristics. 2. Test methods for medical hydrogels, which provide experimental methods for observing the microstructure of medical hydrogels, microbiological testing methods for medical hydrogels, biological evaluation experimental methods, and pH and heavy metal content testing methods.