TBT BSN | Notification

Notification Detail :: G/TBT/N/CHN/1878

Notification No.

Notification Type

Notifying Member

Date of Notification

Final Date for Comments

Days to Final Date

Title

National Standard of the P.R.C., Sterilization of health care products—Radiation—Part 1: Requirements for development, validation and routine control of a sterilization process for medical devices.

Objective

Protection of human health or safety (TBT); Quality requirements (TBT)

Product Covered

Medical devices that are sterilized by radiation using the radionuclides 60cobalt or 137cesium, electron beam from electron generators, and X-ray from X-ray generators (HS code(s): 300590; 392329; 701790; 842129; 901831; 901839; 902131); (ICS code(s): 11.080.01)

Document Notification

Link to ePing

HSCODE

300590 - Wadding, gauze, bandages and the like, e.g. dressings, adhesive plasters, poultices, impregnated or covered with pharmaceutical substances or put up for retail sale for medical, surgical, dental or veterinary purposes (excl. adhesive dressings and other articles having an adhesive layer); 392329 - Sacks and bags, incl. cones, of plastics (excl. those of polymers of ethylene); 701790 - Laboratory, hygienic or pharmaceutical glassware, whether or not graduated or calibrated (excl. glass having a linear coefficient of expansion <= 5 x 10 -6 per kelvin within a temperature range of 0°C to 300°C or of fused quartz or other fused silica, containers for the conveyance or packing of goods, measuring, checking or medical instruments and apparatus of chapter 90); 842129 - Machinery and apparatus for filtering or purifying liquids (excl. such machinery and apparatus for water and other beverages, oil or petrol-filters for internal combustion engines and artificial kidneys); 901831 - Syringes, with or without needles, used in medical, surgical, dental or veterinary sciences; 901839 - Needles, catheters, cannulae and the like, used in medical, surgical, dental or veterinary sciences (excl. syringes, tubular metal needles and needles for sutures); 902131 - Artificial joints for orthopaedic purposes

ICSCODE

11.080.01 - Sterilization and disinfection in general

Keywords

Human health

Specific Regions

Description

This document specifies the requirements for the development, validation, and routine control of medical devices during radiation sterilization processes._x000D_
This document applies to medical devices, but these requirements and provided guidelines can be applied to other products and devices.

Notified Document

1:File here

Link to Notification

EN:File here

FR:File here

ES:File here

Status Active

No	#	Comment By	Title	Comment Date	File

Back

Notification Detail :: G/TBT/N/CHN/1878

Link to ePing

App Settings