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United States

Pacific BioLabs

551 Linus Pauling Dr., 94547, Hercules, CA, United States

A2LA|7312.01ISO/IEC 17025Register refreshed 2026-09-25
Certificates
1
Scope items
4
Standards
27
Locations
1

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Register record

A2LARefreshed
7312.01Active

Accredited standards

27

Our reading of the A2LA scope: each standard once, with its official name where we have checked it. Click a standard to see the scope line it comes from, word for word.

USP

USP 51Name not checked yet
As written on the certificate · Line 2 (A2LA 7312.01)

USP <87>; USP <88>; ASNSI/AAMI/ISO 10993-5; ISO 10993-1; ANSI/AAMI/ISO 10993-12; USP <85>; USP <161>; ANSI/AAMI ST72:2011; EP 2.6.14; USP <51>; USP <71>; USP <61>; ANSI/AAMI/ISO 11737-1; AAMI TIR 33; ANSI/ AAMI/ISO 11137-2 Method 1; ANSI/AAMI/ISO 11137-2; AAMI/ISO TIR 15844; ANSI/AAMI/ISO 11737-2; USP<71>; USP <61>; USP <62>; USP <1111>; EP/BP; ISO 10993-11; USP<151>; 10993-11; 10993-5; USP<87>; 10993-12

USP 61Name not checked yet
As written on the certificate · Line 2 (A2LA 7312.01)

USP <87>; USP <88>; ASNSI/AAMI/ISO 10993-5; ISO 10993-1; ANSI/AAMI/ISO 10993-12; USP <85>; USP <161>; ANSI/AAMI ST72:2011; EP 2.6.14; USP <51>; USP <71>; USP <61>; ANSI/AAMI/ISO 11737-1; AAMI TIR 33; ANSI/ AAMI/ISO 11137-2 Method 1; ANSI/AAMI/ISO 11137-2; AAMI/ISO TIR 15844; ANSI/AAMI/ISO 11737-2; USP<71>; USP <61>; USP <62>; USP <1111>; EP/BP; ISO 10993-11; USP<151>; 10993-11; 10993-5; USP<87>; 10993-12

USP 62Name not checked yet
As written on the certificate · Line 2 (A2LA 7312.01)

USP <87>; USP <88>; ASNSI/AAMI/ISO 10993-5; ISO 10993-1; ANSI/AAMI/ISO 10993-12; USP <85>; USP <161>; ANSI/AAMI ST72:2011; EP 2.6.14; USP <51>; USP <71>; USP <61>; ANSI/AAMI/ISO 11737-1; AAMI TIR 33; ANSI/ AAMI/ISO 11137-2 Method 1; ANSI/AAMI/ISO 11137-2; AAMI/ISO TIR 15844; ANSI/AAMI/ISO 11737-2; USP<71>; USP <61>; USP <62>; USP <1111>; EP/BP; ISO 10993-11; USP<151>; 10993-11; 10993-5; USP<87>; 10993-12

USP 71Name not checked yet
As written on the certificate · Line 2 (A2LA 7312.01)

USP <87>; USP <88>; ASNSI/AAMI/ISO 10993-5; ISO 10993-1; ANSI/AAMI/ISO 10993-12; USP <85>; USP <161>; ANSI/AAMI ST72:2011; EP 2.6.14; USP <51>; USP <71>; USP <61>; ANSI/AAMI/ISO 11737-1; AAMI TIR 33; ANSI/ AAMI/ISO 11137-2 Method 1; ANSI/AAMI/ISO 11137-2; AAMI/ISO TIR 15844; ANSI/AAMI/ISO 11737-2; USP<71>; USP <61>; USP <62>; USP <1111>; EP/BP; ISO 10993-11; USP<151>; 10993-11; 10993-5; USP<87>; 10993-12

USP 85Name not checked yet
As written on the certificate · Line 2 (A2LA 7312.01)

USP <87>; USP <88>; ASNSI/AAMI/ISO 10993-5; ISO 10993-1; ANSI/AAMI/ISO 10993-12; USP <85>; USP <161>; ANSI/AAMI ST72:2011; EP 2.6.14; USP <51>; USP <71>; USP <61>; ANSI/AAMI/ISO 11737-1; AAMI TIR 33; ANSI/ AAMI/ISO 11137-2 Method 1; ANSI/AAMI/ISO 11137-2; AAMI/ISO TIR 15844; ANSI/AAMI/ISO 11737-2; USP<71>; USP <61>; USP <62>; USP <1111>; EP/BP; ISO 10993-11; USP<151>; 10993-11; 10993-5; USP<87>; 10993-12

USP 87Name not checked yet
As written on the certificate · Line 1 (A2LA 7312.01)

ISO/IEC 17025:2017; ISO 10993-6; USP <88>; ISO 10993-11; USP <88>; ISO 10993-23; USP <88>; ISO 10993-11; <USP 151>; European Pharmacopoeia; USP <88>; ISO 10993-10; ISO 10993-10; ISO 10993-23; USP Monograph; EPA/OPPTS 870.1100; USP <123>; USP <121>; AAMI TIR12; ANSI/AAMI/ISO 17665-1; ANSI/AAMI/ISO 14161; USP <87>; ANSI/AAMI/ISO 10993-5; USP <87>; ANSI/ AAMI/ISO 10993-5; ANSI/AAMI/ISO 10993-12

As written on the certificate · Line 2 (A2LA 7312.01)

USP <87>; USP <88>; ASNSI/AAMI/ISO 10993-5; ISO 10993-1; ANSI/AAMI/ISO 10993-12; USP <85>; USP <161>; ANSI/AAMI ST72:2011; EP 2.6.14; USP <51>; USP <71>; USP <61>; ANSI/AAMI/ISO 11737-1; AAMI TIR 33; ANSI/ AAMI/ISO 11137-2 Method 1; ANSI/AAMI/ISO 11137-2; AAMI/ISO TIR 15844; ANSI/AAMI/ISO 11737-2; USP<71>; USP <61>; USP <62>; USP <1111>; EP/BP; ISO 10993-11; USP<151>; 10993-11; 10993-5; USP<87>; 10993-12

USP 88Name not checked yet
As written on the certificate · Line 1 (A2LA 7312.01)

ISO/IEC 17025:2017; ISO 10993-6; USP <88>; ISO 10993-11; USP <88>; ISO 10993-23; USP <88>; ISO 10993-11; <USP 151>; European Pharmacopoeia; USP <88>; ISO 10993-10; ISO 10993-10; ISO 10993-23; USP Monograph; EPA/OPPTS 870.1100; USP <123>; USP <121>; AAMI TIR12; ANSI/AAMI/ISO 17665-1; ANSI/AAMI/ISO 14161; USP <87>; ANSI/AAMI/ISO 10993-5; USP <87>; ANSI/ AAMI/ISO 10993-5; ANSI/AAMI/ISO 10993-12

As written on the certificate · Line 2 (A2LA 7312.01)

USP <87>; USP <88>; ASNSI/AAMI/ISO 10993-5; ISO 10993-1; ANSI/AAMI/ISO 10993-12; USP <85>; USP <161>; ANSI/AAMI ST72:2011; EP 2.6.14; USP <51>; USP <71>; USP <61>; ANSI/AAMI/ISO 11737-1; AAMI TIR 33; ANSI/ AAMI/ISO 11137-2 Method 1; ANSI/AAMI/ISO 11137-2; AAMI/ISO TIR 15844; ANSI/AAMI/ISO 11737-2; USP<71>; USP <61>; USP <62>; USP <1111>; EP/BP; ISO 10993-11; USP<151>; 10993-11; 10993-5; USP<87>; 10993-12

USP 121Name not checked yet
As written on the certificate · Line 1 (A2LA 7312.01)

ISO/IEC 17025:2017; ISO 10993-6; USP <88>; ISO 10993-11; USP <88>; ISO 10993-23; USP <88>; ISO 10993-11; <USP 151>; European Pharmacopoeia; USP <88>; ISO 10993-10; ISO 10993-10; ISO 10993-23; USP Monograph; EPA/OPPTS 870.1100; USP <123>; USP <121>; AAMI TIR12; ANSI/AAMI/ISO 17665-1; ANSI/AAMI/ISO 14161; USP <87>; ANSI/AAMI/ISO 10993-5; USP <87>; ANSI/ AAMI/ISO 10993-5; ANSI/AAMI/ISO 10993-12

USP 123Name not checked yet
As written on the certificate · Line 1 (A2LA 7312.01)

ISO/IEC 17025:2017; ISO 10993-6; USP <88>; ISO 10993-11; USP <88>; ISO 10993-23; USP <88>; ISO 10993-11; <USP 151>; European Pharmacopoeia; USP <88>; ISO 10993-10; ISO 10993-10; ISO 10993-23; USP Monograph; EPA/OPPTS 870.1100; USP <123>; USP <121>; AAMI TIR12; ANSI/AAMI/ISO 17665-1; ANSI/AAMI/ISO 14161; USP <87>; ANSI/AAMI/ISO 10993-5; USP <87>; ANSI/ AAMI/ISO 10993-5; ANSI/AAMI/ISO 10993-12

USP 151Name not checked yet
As written on the certificate · Line 1 (A2LA 7312.01)

ISO/IEC 17025:2017; ISO 10993-6; USP <88>; ISO 10993-11; USP <88>; ISO 10993-23; USP <88>; ISO 10993-11; <USP 151>; European Pharmacopoeia; USP <88>; ISO 10993-10; ISO 10993-10; ISO 10993-23; USP Monograph; EPA/OPPTS 870.1100; USP <123>; USP <121>; AAMI TIR12; ANSI/AAMI/ISO 17665-1; ANSI/AAMI/ISO 14161; USP <87>; ANSI/AAMI/ISO 10993-5; USP <87>; ANSI/ AAMI/ISO 10993-5; ANSI/AAMI/ISO 10993-12

As written on the certificate · Line 2 (A2LA 7312.01)

USP <87>; USP <88>; ASNSI/AAMI/ISO 10993-5; ISO 10993-1; ANSI/AAMI/ISO 10993-12; USP <85>; USP <161>; ANSI/AAMI ST72:2011; EP 2.6.14; USP <51>; USP <71>; USP <61>; ANSI/AAMI/ISO 11737-1; AAMI TIR 33; ANSI/ AAMI/ISO 11137-2 Method 1; ANSI/AAMI/ISO 11137-2; AAMI/ISO TIR 15844; ANSI/AAMI/ISO 11737-2; USP<71>; USP <61>; USP <62>; USP <1111>; EP/BP; ISO 10993-11; USP<151>; 10993-11; 10993-5; USP<87>; 10993-12

USP 161Name not checked yet
As written on the certificate · Line 2 (A2LA 7312.01)

USP <87>; USP <88>; ASNSI/AAMI/ISO 10993-5; ISO 10993-1; ANSI/AAMI/ISO 10993-12; USP <85>; USP <161>; ANSI/AAMI ST72:2011; EP 2.6.14; USP <51>; USP <71>; USP <61>; ANSI/AAMI/ISO 11737-1; AAMI TIR 33; ANSI/ AAMI/ISO 11137-2 Method 1; ANSI/AAMI/ISO 11137-2; AAMI/ISO TIR 15844; ANSI/AAMI/ISO 11737-2; USP<71>; USP <61>; USP <62>; USP <1111>; EP/BP; ISO 10993-11; USP<151>; 10993-11; 10993-5; USP<87>; 10993-12

USP 643Name not checked yet
As written on the certificate · Line 3 (A2LA 7312.01)

USP <645>; USP <643>; ISO 10993-18

USP 645Name not checked yet
As written on the certificate · Line 3 (A2LA 7312.01)

USP <645>; USP <643>; ISO 10993-18

USP 1111Name not checked yet
As written on the certificate · Line 2 (A2LA 7312.01)

USP <87>; USP <88>; ASNSI/AAMI/ISO 10993-5; ISO 10993-1; ANSI/AAMI/ISO 10993-12; USP <85>; USP <161>; ANSI/AAMI ST72:2011; EP 2.6.14; USP <51>; USP <71>; USP <61>; ANSI/AAMI/ISO 11737-1; AAMI TIR 33; ANSI/ AAMI/ISO 11137-2 Method 1; ANSI/AAMI/ISO 11137-2; AAMI/ISO TIR 15844; ANSI/AAMI/ISO 11737-2; USP<71>; USP <61>; USP <62>; USP <1111>; EP/BP; ISO 10993-11; USP<151>; 10993-11; 10993-5; USP<87>; 10993-12

ISO 10993 series

ISO 10993-1Biological evaluation of medical devices - Part 1: Requirements and general principles for the evaluation of biological safety within a risk management process
As written on the certificate · Line 2 (A2LA 7312.01)

USP <87>; USP <88>; ASNSI/AAMI/ISO 10993-5; ISO 10993-1; ANSI/AAMI/ISO 10993-12; USP <85>; USP <161>; ANSI/AAMI ST72:2011; EP 2.6.14; USP <51>; USP <71>; USP <61>; ANSI/AAMI/ISO 11737-1; AAMI TIR 33; ANSI/ AAMI/ISO 11137-2 Method 1; ANSI/AAMI/ISO 11137-2; AAMI/ISO TIR 15844; ANSI/AAMI/ISO 11737-2; USP<71>; USP <61>; USP <62>; USP <1111>; EP/BP; ISO 10993-11; USP<151>; 10993-11; 10993-5; USP<87>; 10993-12

ISO 10993-5Biological evaluation of medical devices - Part 5: Tests for in vitro cytotoxicity
As written on the certificate · Line 1 (A2LA 7312.01)

ISO/IEC 17025:2017; ISO 10993-6; USP <88>; ISO 10993-11; USP <88>; ISO 10993-23; USP <88>; ISO 10993-11; <USP 151>; European Pharmacopoeia; USP <88>; ISO 10993-10; ISO 10993-10; ISO 10993-23; USP Monograph; EPA/OPPTS 870.1100; USP <123>; USP <121>; AAMI TIR12; ANSI/AAMI/ISO 17665-1; ANSI/AAMI/ISO 14161; USP <87>; ANSI/AAMI/ISO 10993-5; USP <87>; ANSI/ AAMI/ISO 10993-5; ANSI/AAMI/ISO 10993-12

As written on the certificate · Line 2 (A2LA 7312.01)

USP <87>; USP <88>; ASNSI/AAMI/ISO 10993-5; ISO 10993-1; ANSI/AAMI/ISO 10993-12; USP <85>; USP <161>; ANSI/AAMI ST72:2011; EP 2.6.14; USP <51>; USP <71>; USP <61>; ANSI/AAMI/ISO 11737-1; AAMI TIR 33; ANSI/ AAMI/ISO 11137-2 Method 1; ANSI/AAMI/ISO 11137-2; AAMI/ISO TIR 15844; ANSI/AAMI/ISO 11737-2; USP<71>; USP <61>; USP <62>; USP <1111>; EP/BP; ISO 10993-11; USP<151>; 10993-11; 10993-5; USP<87>; 10993-12

ISO 10993-6Biological evaluation of medical devices - Part 6: Tests for local effects after implantation
As written on the certificate · Line 1 (A2LA 7312.01)

ISO/IEC 17025:2017; ISO 10993-6; USP <88>; ISO 10993-11; USP <88>; ISO 10993-23; USP <88>; ISO 10993-11; <USP 151>; European Pharmacopoeia; USP <88>; ISO 10993-10; ISO 10993-10; ISO 10993-23; USP Monograph; EPA/OPPTS 870.1100; USP <123>; USP <121>; AAMI TIR12; ANSI/AAMI/ISO 17665-1; ANSI/AAMI/ISO 14161; USP <87>; ANSI/AAMI/ISO 10993-5; USP <87>; ANSI/ AAMI/ISO 10993-5; ANSI/AAMI/ISO 10993-12

ISO 10993-10Biological evaluation of medical devices - Part 10: Tests for skin sensitization
As written on the certificate · Line 1 (A2LA 7312.01)

ISO/IEC 17025:2017; ISO 10993-6; USP <88>; ISO 10993-11; USP <88>; ISO 10993-23; USP <88>; ISO 10993-11; <USP 151>; European Pharmacopoeia; USP <88>; ISO 10993-10; ISO 10993-10; ISO 10993-23; USP Monograph; EPA/OPPTS 870.1100; USP <123>; USP <121>; AAMI TIR12; ANSI/AAMI/ISO 17665-1; ANSI/AAMI/ISO 14161; USP <87>; ANSI/AAMI/ISO 10993-5; USP <87>; ANSI/ AAMI/ISO 10993-5; ANSI/AAMI/ISO 10993-12

ISO 10993-11Biological evaluation of medical devices - Part 11: Tests for systemic toxicity
As written on the certificate · Line 1 (A2LA 7312.01)

ISO/IEC 17025:2017; ISO 10993-6; USP <88>; ISO 10993-11; USP <88>; ISO 10993-23; USP <88>; ISO 10993-11; <USP 151>; European Pharmacopoeia; USP <88>; ISO 10993-10; ISO 10993-10; ISO 10993-23; USP Monograph; EPA/OPPTS 870.1100; USP <123>; USP <121>; AAMI TIR12; ANSI/AAMI/ISO 17665-1; ANSI/AAMI/ISO 14161; USP <87>; ANSI/AAMI/ISO 10993-5; USP <87>; ANSI/ AAMI/ISO 10993-5; ANSI/AAMI/ISO 10993-12

As written on the certificate · Line 2 (A2LA 7312.01)

USP <87>; USP <88>; ASNSI/AAMI/ISO 10993-5; ISO 10993-1; ANSI/AAMI/ISO 10993-12; USP <85>; USP <161>; ANSI/AAMI ST72:2011; EP 2.6.14; USP <51>; USP <71>; USP <61>; ANSI/AAMI/ISO 11737-1; AAMI TIR 33; ANSI/ AAMI/ISO 11137-2 Method 1; ANSI/AAMI/ISO 11137-2; AAMI/ISO TIR 15844; ANSI/AAMI/ISO 11737-2; USP<71>; USP <61>; USP <62>; USP <1111>; EP/BP; ISO 10993-11; USP<151>; 10993-11; 10993-5; USP<87>; 10993-12

ISO 10993-12Biological evaluation of medical devices - Part 12: Sample preparation and reference materials
As written on the certificate · Line 1 (A2LA 7312.01)

ISO/IEC 17025:2017; ISO 10993-6; USP <88>; ISO 10993-11; USP <88>; ISO 10993-23; USP <88>; ISO 10993-11; <USP 151>; European Pharmacopoeia; USP <88>; ISO 10993-10; ISO 10993-10; ISO 10993-23; USP Monograph; EPA/OPPTS 870.1100; USP <123>; USP <121>; AAMI TIR12; ANSI/AAMI/ISO 17665-1; ANSI/AAMI/ISO 14161; USP <87>; ANSI/AAMI/ISO 10993-5; USP <87>; ANSI/ AAMI/ISO 10993-5; ANSI/AAMI/ISO 10993-12

As written on the certificate · Line 2 (A2LA 7312.01)

USP <87>; USP <88>; ASNSI/AAMI/ISO 10993-5; ISO 10993-1; ANSI/AAMI/ISO 10993-12; USP <85>; USP <161>; ANSI/AAMI ST72:2011; EP 2.6.14; USP <51>; USP <71>; USP <61>; ANSI/AAMI/ISO 11737-1; AAMI TIR 33; ANSI/ AAMI/ISO 11137-2 Method 1; ANSI/AAMI/ISO 11137-2; AAMI/ISO TIR 15844; ANSI/AAMI/ISO 11737-2; USP<71>; USP <61>; USP <62>; USP <1111>; EP/BP; ISO 10993-11; USP<151>; 10993-11; 10993-5; USP<87>; 10993-12

ISO 10993-18Biological evaluation of medical devices - Part 18: Chemical characterization of medical device materials within a risk management process
As written on the certificate · Line 3 (A2LA 7312.01)

USP <645>; USP <643>; ISO 10993-18

ISO 10993-23Biological evaluation of medical devices - Part 23: Tests for irritation
As written on the certificate · Line 1 (A2LA 7312.01)

ISO/IEC 17025:2017; ISO 10993-6; USP <88>; ISO 10993-11; USP <88>; ISO 10993-23; USP <88>; ISO 10993-11; <USP 151>; European Pharmacopoeia; USP <88>; ISO 10993-10; ISO 10993-10; ISO 10993-23; USP Monograph; EPA/OPPTS 870.1100; USP <123>; USP <121>; AAMI TIR12; ANSI/AAMI/ISO 17665-1; ANSI/AAMI/ISO 14161; USP <87>; ANSI/AAMI/ISO 10993-5; USP <87>; ANSI/ AAMI/ISO 10993-5; ANSI/AAMI/ISO 10993-12

ISO

ISO 11137-2Sterilization of health care products - Radiation - Part 2: Establishing the sterilization dose
As written on the certificate · Line 2 (A2LA 7312.01)

USP <87>; USP <88>; ASNSI/AAMI/ISO 10993-5; ISO 10993-1; ANSI/AAMI/ISO 10993-12; USP <85>; USP <161>; ANSI/AAMI ST72:2011; EP 2.6.14; USP <51>; USP <71>; USP <61>; ANSI/AAMI/ISO 11737-1; AAMI TIR 33; ANSI/ AAMI/ISO 11137-2 Method 1; ANSI/AAMI/ISO 11137-2; AAMI/ISO TIR 15844; ANSI/AAMI/ISO 11737-2; USP<71>; USP <61>; USP <62>; USP <1111>; EP/BP; ISO 10993-11; USP<151>; 10993-11; 10993-5; USP<87>; 10993-12

ISO 11737-1Sterilization of health care products - Microbiological methods - Part 1: Determination of a population of microorganisms on products
As written on the certificate · Line 2 (A2LA 7312.01)

USP <87>; USP <88>; ASNSI/AAMI/ISO 10993-5; ISO 10993-1; ANSI/AAMI/ISO 10993-12; USP <85>; USP <161>; ANSI/AAMI ST72:2011; EP 2.6.14; USP <51>; USP <71>; USP <61>; ANSI/AAMI/ISO 11737-1; AAMI TIR 33; ANSI/ AAMI/ISO 11137-2 Method 1; ANSI/AAMI/ISO 11137-2; AAMI/ISO TIR 15844; ANSI/AAMI/ISO 11737-2; USP<71>; USP <61>; USP <62>; USP <1111>; EP/BP; ISO 10993-11; USP<151>; 10993-11; 10993-5; USP<87>; 10993-12

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
As written on the certificate · Line 2 (A2LA 7312.01)

USP <87>; USP <88>; ASNSI/AAMI/ISO 10993-5; ISO 10993-1; ANSI/AAMI/ISO 10993-12; USP <85>; USP <161>; ANSI/AAMI ST72:2011; EP 2.6.14; USP <51>; USP <71>; USP <61>; ANSI/AAMI/ISO 11737-1; AAMI TIR 33; ANSI/ AAMI/ISO 11137-2 Method 1; ANSI/AAMI/ISO 11137-2; AAMI/ISO TIR 15844; ANSI/AAMI/ISO 11737-2; USP<71>; USP <61>; USP <62>; USP <1111>; EP/BP; ISO 10993-11; USP<151>; 10993-11; 10993-5; USP<87>; 10993-12

ISO 14161Sterilization of health care products - Biological indicators - Guidance for the selection, use and interpretation of results
As written on the certificate · Line 1 (A2LA 7312.01)

ISO/IEC 17025:2017; ISO 10993-6; USP <88>; ISO 10993-11; USP <88>; ISO 10993-23; USP <88>; ISO 10993-11; <USP 151>; European Pharmacopoeia; USP <88>; ISO 10993-10; ISO 10993-10; ISO 10993-23; USP Monograph; EPA/OPPTS 870.1100; USP <123>; USP <121>; AAMI TIR12; ANSI/AAMI/ISO 17665-1; ANSI/AAMI/ISO 14161; USP <87>; ANSI/AAMI/ISO 10993-5; USP <87>; ANSI/ AAMI/ISO 10993-5; ANSI/AAMI/ISO 10993-12

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
As written on the certificate · Line 1 (A2LA 7312.01)

ISO/IEC 17025:2017; ISO 10993-6; USP <88>; ISO 10993-11; USP <88>; ISO 10993-23; USP <88>; ISO 10993-11; <USP 151>; European Pharmacopoeia; USP <88>; ISO 10993-10; ISO 10993-10; ISO 10993-23; USP Monograph; EPA/OPPTS 870.1100; USP <123>; USP <121>; AAMI TIR12; ANSI/AAMI/ISO 17665-1; ANSI/AAMI/ISO 14161; USP <87>; ANSI/AAMI/ISO 10993-5; USP <87>; ANSI/ AAMI/ISO 10993-5; ANSI/AAMI/ISO 10993-12

Scope as published by A2LA

4 lines
A2LA

ISO/IEC 17025

Active

7312.01

The scope document we hold says it is valid until 2027-01-31.

View scope

Accredited scope, certificate 7312.01

LineDisciplineMethodMatrixRange
1biologicalISO/IEC 17025:2017; ISO 10993-6; USP <88>; ISO 10993-11; USP <88>; ISO 10993-23; USP <88>; ISO 10993-11; <USP 151>; European Pharmacopoeia; USP <88>; ISO 10993-10; ISO 10993-10; ISO 10993-23; USP Monograph; EPA/OPPTS 870.1100; USP <123>; USP <121>; AAMI TIR12; ANSI/AAMI/ISO 17665-1; ANSI/AAMI/ISO 14161; USP <87>; ANSI/AAMI/ISO 10993-5; USP <87>; ANSI/ AAMI/ISO 10993-5; ANSI/AAMI/ISO 10993-12Medical devices-
2biologicalUSP <87>; USP <88>; ASNSI/AAMI/ISO 10993-5; ISO 10993-1; ANSI/AAMI/ISO 10993-12; USP <85>; USP <161>; ANSI/AAMI ST72:2011; EP 2.6.14; USP <51>; USP <71>; USP <61>; ANSI/AAMI/ISO 11737-1; AAMI TIR 33; ANSI/ AAMI/ISO 11137-2 Method 1; ANSI/AAMI/ISO 11137-2; AAMI/ISO TIR 15844; ANSI/AAMI/ISO 11737-2; USP<71>; USP <61>; USP <62>; USP <1111>; EP/BP; ISO 10993-11; USP<151>; 10993-11; 10993-5; USP<87>; 10993-12--
3chemicalUSP <645>; USP <643>; ISO 10993-18--
4biologicalISO/IEC 17025:2017; A2LA R256 - Specific Requirements - FDA ASCA Program--

Ranges are reproduced from the accredited scope document as published. 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.

Location

551 Linus Pauling Dr., Hercules, CA, 94547, US

38.01714, -122.28858

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