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YY/T 1295-2015 (YYT 1295-2015)

YY/T 1295-2015_English: PDF (YYT1295-2015)
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YY/T 1295-2015English489 Add to Cart 4 days Biological evaluation of medical devices. Nanomaterial: Endotoxin test YY/T 1295-2015 Valid YY/T 1295-2015

BASIC DATA
Standard ID YY/T 1295-2015 (YY/T1295-2015)
Description (Translated English) Biological evaluation of medical devices. Nanomaterial: Endotoxin test
Sector / Industry Medical Device & Pharmaceutical Industry Standard (Recommended)
Classification of Chinese Standard C30
Classification of International Standard 11.040.30
Word Count Estimation 22,296
Date of Issue 2015-03-02
Date of Implementation 2016-01-01
Quoted Standard GB/T 16886.12; GB/T 25915.1; GB/T 25915.2; GB/T 25915.7; ISO 10993-12-2007
Adopted Standard ISO 29701-2010, MOD
Drafting Organization Chinese Institute of Food and Drug test
Administrative Organization Chinese Institute of Food and Drug test
Regulation (derived from) The State Food and Drug Administration Announcement 2015 No. 8
Proposing organization China Food and Drug Administration
Issuing agency(ies) China Food and Drug Administration
Summary This Standard specifies the application of the Limulus test evaluation of nanomaterials, for in vitro biological assay system cells. This Standard applies to be an aqueous medium (for example: water, serum or reaction medium) or extracts dispersed nanomaterials, making nanomaterials with such culture medium at an appropriate time 37��C. This Standard is limited to in vitro test sample, the method can also be applied to animal by the parenteral route of administration of nanomaterials.

YY/T 1295-2015
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
C