YY/T 0464-2019Disposable haemoperfusion devices (English PDF)

Foreword

This standard was drafted in accordance with the rules given in GB/T 1.1-2009.

This standard replaces YY 0464-2009 "Disposable blood perfusion device". Compared with YY 0464-2009, this standard Apart from the modifications, the main technical changes are as follows.

--- Modified terms and definitions (see Chapter 3, Chapter 3 of the 2009 edition);

--- Modified classification and naming (see Chapter 4, Chapter 4 of the 2009 edition);

--- Increased the connection requirements of blood inlet and outlet ends and tubing (see 5.2);

--- Increased the content of packed sorbent (see 5.3);

--- Modified the test method for particle shedding (see Appendix A, Appendix A of the 2009 edition);

--- Modified the chemical sample preparation method (see 6.6.1, 2009 version 6.4.1);

--- Defined the sample preparation method of pyrogen test solution (see 6.9, 2009 version 6.5.3);

--- Increased bacterial endotoxin content requirements (see 5.10);

--- Increased the note on adsorption performance requirements (see 5.12, 2009 version 5.7);

--- The sampling method for adsorption performance has increased the option of directly weighing the adsorbent after constant weight for selection (see 6.12.1, 2009 version 6.7.1);

--- Increased the performance requirements for the validity period (see 5.14);

--- Deleted the inspection rules (see Chapter 7 of the 2009 edition);

--- Revised the requirements for signs and instructions (see Chapter 7, Chapter 8 of the 2009 edition);

--- Revised storage requirements (see 8.3, 2009 version 9.3).

1 Scope

This standard specifies the terms and definitions, classification and model designation, requirements, test methods, signs and instructions of single-use blood perfusion devices. Books and packaging, transportation, storage.

This standard applies to single-use blood perfusion devices (hereinafter referred to as perfusion devices) that use adsorbents such as activated carbon or adsorption resin.

The device cooperates with a blood purification device for blood perfusion, and removes endogenous and exogenous drugs, poisons and metabolites from the patient's body.

2 Normative references

The following documents are essential for the application of this document. For dated references, only the dated version applies to this document. For undated references, the latest version (including all amendments) applies to this document.

GB/T 191 Packaging, storage and transportation pictograms (GB/T 191-2008, ISO 780.:1997, MOD)

GB/T 13074 blood purification term (GB/T 13074-2009)

GB/T 14233.1-2008 Test methods for medical infusions, blood transfusions and syringes-Part 1. Chemical analysis

GB/T 16886.1 Biological evaluation of medical devices Part 1. Evaluation and testing in the process of risk management (GB/T 16886.1- (2011, ISO 10993-1.:2009, IDT)

GB/T 16886.4 Biological evaluation of medical devices. Part 4. Selection of tests for interaction with blood (GB/T 16886.4- 2003, ISO 10993-4.:2002, IDT)

GB/T 16886.5 Biological evaluation of medical devices Part 5. In vitro cytotoxicity test (GB/T 16886.5-2017, (ISO 10993-5.:2009, IDT)

GB/T 16886.10 Biological evaluation of medical devices Part 10. Irritation and skin sensitization test (GB/T 16886.10-2017, (ISO 10993-10.:2010, IDT)

GB/T 16886.11 Biological evaluation of medical devices Part 11. Systemic toxicity test (GB/T 16886.11-2011, (ISO 10993-11.:2006, IDT) Pharmacopoeia of the People's Republic of China (2015 Edition)

3 Terms and definitions

The terms and definitions defined in GB/T 13074 apply to this document.

4 Classification and model designation