YY 0465-2019Valid

Disposable membrane plasma separator and plasma component separator

一次性使用空心纤维血浆分离器和血浆成分分离器

Issued by

National Medical Products Administration (NMPA)

Level / Type

Industry · Mandatory

Issue date

May 31, 2019

Implementation date

June 1, 2020

Scope

This standard specifies the terminology, types, technical requirements, test methods, inspection rules, marking, packaging, transport and storage for disposable hollow-fiber membrane plasma separators and plasma component separators used in therapeutic plasma exchange and plasma collection procedures.

Table of Contents

  1. 1.Scope
  2. 2.Normative References
  3. 3.Terms and Definitions
  4. 4.Types and Model Designation
  5. 5.Technical Requirements
  6. 6.Test Methods
  7. 7.Inspection Rules
  8. 8.Marking, Packaging, Transport and Storage

Related Standards

YY/T 0287-2017Valid

Medical devices — Quality management systems — Requirements for regulatory purposes

Industry·Recommended·Medicine & Medical
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