YY/T 1295-2015Biological evaluation of medical devices—Nanomaterial:Endotoxin test (English PDF)
医疗器械生物学评价 纳米材料：细菌内毒素试验
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Issued by
NMPA
Level / Type
Industry · Recommended
Issue date
March 2, 2015
Implementation date
January 1, 2016
Scope
YY/T 1295-2015 is the English-translated version of 医疗器械生物学评价 纳米材料：细菌内毒素试验.
YY/T 1295-2015 is the Chinese pharmaceutical industry standard that describes the use of the limulus amoebocyte lysate test to evaluate the endotoxin content of nanomaterials, including those tested in an in vitro biological assay on cells.
It applies to nanomaterials that can be dispersed or leached in an aqueous medium, water, serum or the reaction medium, and it sets out the preparation of the sample, the interference the nanomaterial can cause in the test and how it is checked for, and the way the result is judged. Issued on 2 March 2015, it has applied since 1 January 2016.
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Document preview — YY/T 1295-2015
National Standard of the People's Republic of China
- ICS
- 11.040.30
- Classification
- C 30
Issued by: National Medical Products Administration of the People's Republic of China
Contents
- Preface
- 1 Scope
- 2 Normative references
- 3 Terms and definitions
- 4 Abbreviations
- 6 for the test
- 7 for the sample preparation
- 8 Test Method
- 9 results of the evaluation
- 10 Test Report
- Appendix A (informative) Examples of potential interference Limulus test
- Annex B (informative) gel method
- Annex C (informative) spectrophotometric end
- Annex D (informative) Dynamic Method
- References
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.
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 °C.
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.
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
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
Gram-negative bacteria cell wall of a component of the outer membrane.
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This preview omits tables, figures, formulas and parts of the technical clauses. The complete document — 18 pages — is available in the English PDF.
Referenced standards
Normative references
- GB/T 16886.12Biological evaluation of medical devices - Part 12: Sample preparation and reference materials
- GB/T 25915.1Cleanrooms and associated controlled environments - Part 1: Classification of air cleanliness by particle concentration
- GB/T 25915.2Cleanrooms and associated controlled environments - Part 2: Monitoring to provide evidence of cleanroom performance related to air cleanliness by particle concentration
- GB/T 25915.7Cleanrooms and associated controlled environments -- Part 7: Separative devices (clean air hoods, gloveboxes, isolators and minienvironments)
ISO 10993-12:2007
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Related Standards
GB/T 16886.12-2023 — Biological evaluation of medical devices - Part 12: Sample preparation and reference materials
GB/T 25915.1-2021 — Cleanrooms and associated controlled environments - Part 1: Classification of air cleanliness by particle concentration
GB/T 25915.2-2021 — Cleanrooms and associated controlled environments - Part 2: Monitoring to provide evidence of cleanroom performance related to air cleanliness by particle concentration
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