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YY/T 1295-2015: Biological evaluation of medical devices. Nanomaterial: Endotoxin test
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YY/T 1295-2015: Biological evaluation of medical devices. Nanomaterial: Endotoxin test

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Biological evaluation of medical devices.Nanomaterial. Endotoxin test ICS 11.040.30 C30 People's Republic of China pharmaceutical industry standards Biological evaluation of medical devices Nanomaterials. bacterial endotoxin test Endotoxintest [ISO 29701.2010, Nanotechnologies-Endotoxintestonnanomaterial samplesforinvitrosystems-Limulusamebocytelysate (LAL) test, MOD] Issued on. 2015-03-02 2016-01-01 implementation China Food and Drug Administration released

Table of Contents

Preface Ⅰ 1 Scope 1 2 Normative references 1 3 Terms and definitions 4 Abbreviations 2 Top 5 Test preparation 2 6 for the test 3 7 for the sample preparation 3 8 Test Method 4 9 results of the evaluation 5 10 Test Report 6 Appendix A (informative) Examples of potential interference Limulus test 7 Annex B (informative) gel method 8 Annex C (informative) spectrophotometric end 11 Annex D (informative) Dynamic Method 14 Annex E (informative) The standards with international standards reg number and a list of technical differences between the control and the list of 16 reasons References 18

Foreword

This standard was drafted in accordance with GB/T 1.1-2009 given rules. This revised standard adopts ISO 29701.2010 "within nanotechnology nanomaterials samples of in vitro bacterial endotoxin test. Limulus test." The standard Registration and ISO 29701.2010 compared, on the structure set out in Table E.1 lists this standard and ISO 29701. reg number for 2010 According to the table. This standard and ISO 29701.2010 technical differences exist compared to Table E.2 gives the corresponding technical differences and their causes. Please note that some of the content of this document may involve patents. Release mechanism of the present document does not assume responsibility for the identification of these patents. This standard was proposed by the China Food and Drug Administration. This standard is the focal point for the Chinese Institute of Food and Drug test. This standard was drafted. Chinese Academy of Food and Drug test. The main drafters of this standard. Chen Dandan, Xu Liming, Huang Qingquan, Shao Anliang, Feng Xiaoming, Wang Chunren. Biological evaluation of medical devices Nanomaterials. bacterial endotoxin test

1 Scope

This standard describes the use of Limulus test evaluation of nanomaterials, for in vitro biological assay system cells. This standard applies to the aqueous medium can be. nanomaterials (such as water, serum or reaction medium) dispersed or leaching, nano materials and This culture medium at an appropriate time 37 ℃. This standard is limited to in vitro testing samples, the method is also applicable to animal by the parenteral route of administration nanomaterials.

2 Normative references

The following documents for the application of this document is essential. For dated references, only the dated version suitable for use herein Member. For undated references, the latest edition (including any amendments) applies to this document. GB/T 16886.12 Biological evaluation of medical devices - Part 12. Sample preparation and reference materials (GB/T 16886.12- 2005, ISO 10993-12.2002, IDT) GB/T 25915.1 cleanroom and associated controlled environments - Part 1. air cleanliness class (GB/T 25915.1-2010, ISO 14644-1.1999, IDT) GB/T 25915.2 cleanroom and associated controlled environments - Part 2. demonstrate continuous compliance with GB/T 25915.1 Detection and Monitoring Technical conditions (GB/T 25915.2-2010, ISO 14644-2.2000, IDT) GB/T 25915.7 cleanroom and associated controlled environments - Part 7. isolation device (clean hoods, glove boxes, isolators, micro-ring Habitat) (GB/T 25915.7-2010, ISO 14644-7.2004, IDT) People's Republic of China Pharmacopoeia (three), 2010 Edition ISO 10993-12.2007 Biological evaluation of medical devices - Part 12. Sample preparation and reference materials (Biologicalevalua- tionofmedicaldevices-Part 12. Samplepreparationandreferencematerials)

3 Terms and Definitions

The following terms and definitions apply to this document. 3.1 Coagulogens coagulogen LAL endotoxin-induced gel formation plays a major role in coagulation proteins. NOTE. coagulogens the 175 amino acids, relative molecular mass of 19723. 3.2 Coagulated protein coagulin LAL solidification plasminogen activator coagulated fibrinogen is converted to protein coagulation. Note. The coagulated protein from the N-terminal fragment of polypeptide (Ala1-Arg18) and C-terminal fragment of polypeptide (Gly47-Phe175) components. 3.3 Endotoxin endotoxin Gram-negative bacteria cell wall of a component of the outer membrane. ...