Qumran (Suzhou) Medical Technology Co.,
4F, B16, Liando U Vally, No.200 Xingpu Road, Suzhou Industrial Park, suzhou, People's Republic of China, suzhou, China
- Accredited standards
- 16
- A2LA certificate
- 1
- Site in our directory
- 1
What this lab is accredited for
Our reading of the A2LA scope: each standard once, with its official name where we have checked it.
Only this lab. Searches the 16 standard numbers and the 11 official names we hold. When no standard matches, it searches the method text of every scope line.
ISO8
ISO 10993-5Biological evaluation of medical devices - Part 5: Tests for in vitro cytotoxicity
ISO 10993-12Biological evaluation of medical devices - Part 12: Sample preparation and reference materials
ISO 11737-1Sterilization of health care products - Microbiological methods - Part 1: Determination of a population of microorganisms on products
ISO 11737-2Sterilization of health care products - Microbiological methods - Part 2: Tests of sterility performed in the definition, validation and maintenance of a sterilization process
ISO 17664-1Processing of health care products - Information to be provided by the medical device manufacturer for the processing of medical devices - Part 1: Critical and semi-critical medical devices
ISO 17664-2Processing of health care products - Information to be provided by the medical device manufacturer for the processing of medical devices - Part 2: Non-critical medical devices
ISO 17665-1Sterilization of health care products - Moist heat - Part 1: Requirements for the development, validation and routine control of a sterilization process for medical devices
ISO 22441Sterilization of health care products - Low temperature vaporized hydrogen peroxide - Requirements for the development, validation and routine control of a sterilization process for medical devices
ASTM3
ASTM F3208
ASTM F3293
ASTM F3438
ISO 15883 series3
ISO 15883-1Washer-disinfectors - Part 1: General requirements, terms and definitions and tests
ISO 15883-2Washer-disinfectors - Part 2: Requirements and tests for washer-disinfectors employing thermal disinfection for critical and semi-critical medical devices
ISO 15883-5Washer-disinfectors - Part 5: Performance requirements and test method criteria for demonstrating cleaning efficacy
Other standards2
EN 285
EN 13060
ISO 10993-5; EN ISO 10993-5; GB/T 16886.5; ISO 10993-12; EN ISO 10993-12; GB/T 16886.12; ANSI/AAMI ST98; YY/T 1495; ASTM F3293; ASTM F3438; ASTM F3208; ISO 15883-1; EN ISO 15883-1; YY/T 0734.1
ISO 15883-2; EN ISO 15883-2; YY/T 0734.2; ISO 15883-5; EN ISO 15883-5; AAMI TIR 12; ISO 17664-1; EN ISO 17664-1; ISO 17664-2; EN ISO 17664-2; YY/T 0802; ISO 22441; GB/T 19973.1; ISO 11737-1; EN ISO 11737-1; GB/T 19973.2; ISO 11737-2; EN ISO 11737-2; GB 18278.1; ISO 17665-1; EN ISO 17665-1; ANSI/AAMI ST8; GB/T 30690; EN 13060; EN 285; ANSI/AAMI ST55; GB 8599
Read from the A2LA scope document we downloaded on 2026-03-14. Register refreshed 2026-11-06.
Scope as published by A2LA
3 lines
ISO/IEC 17025
Active7221.01
The scope document we hold says it was valid until 2026-03-31. That date has passed, so our copy may be out of date. We downloaded it from the A2LA register on 2026-03-14. Check the A2LA register for the current scope.
Accredited scope, certificate 7221.01
| Line | Method | Matrix | Range |
|---|---|---|---|
| 1 | ISO 10993-5; EN ISO 10993-5; GB/T 16886.5; ISO 10993-12; EN ISO 10993-12; GB/T 16886.12; ANSI/AAMI ST98; YY/T 1495; ASTM F3293; ASTM F3438; ASTM F3208; ISO 15883-1; EN ISO 15883-1; YY/T 0734.1 | Medical devices | - |
| 2 | ISO 15883-2; EN ISO 15883-2; YY/T 0734.2; ISO 15883-5; EN ISO 15883-5; AAMI TIR 12; ISO 17664-1; EN ISO 17664-1; ISO 17664-2; EN ISO 17664-2; YY/T 0802; ISO 22441; GB/T 19973.1; ISO 11737-1; EN ISO 11737-1; GB/T 19973.2; ISO 11737-2; EN ISO 11737-2; GB 18278.1; ISO 17665-1; EN ISO 17665-1; ANSI/AAMI ST8; GB/T 30690; EN 13060; EN 285; ANSI/AAMI ST55; GB 8599 | - | - |
| 3 | Extracted from the scope document; tables may not line up. View scope for the original. For the tests to which this accreditation applies, please refer to the laboratory’s Chemical Scope of Accreditation.
Accredited Laboratory
A2LA has accredited
QUMRAN (SUZHOU) MEDICAL TECHNOLOGY CO., LTD
Suzhou, PEOPLE’S REPUBLIC OF CHINA
for technical competence in the field of
Biological Testing
This laboratory is accredited in accordance with the recognized International Standard ISO/IEC 17025:2017
General requirements for the competence of testing and calibration laboratories. This accreditation demonstrates
technical competence for a defined scope and the operation of a laboratory quality management system (refer to
joint ISO-ILAC-IAF Communiqué dated April 2017).
Presented this 12th day of April, 2024.
_______________________
Mr. Trace McInturff, Vice President, Accreditation Services
For the Accreditation Council
Certificate Number 7221.01
Valid to March 31, 2026
Revised February 17, 2026 | ||
Ranges are reproduced from the accredited scope document as published, and only where we found that range printed in the document for the line. Otherwise the cell reads “See scope document”. An absent range means the register did not state one. Line numbers are ours, for cross-reference; they follow the order of the scope document.
Labs with overlapping accredited scope in China
Accreditation data refreshed from the A2LA register on .
This page mirrors a public register. For a purchasing, audit or regulatory decision, confirm against the A2LA entry linked above.