Poland

Europejski Instytut Biomedyczny

ul. Nałkowskiej 5, 05-410, Józefów, Poland

PCA|AB 1763ISO/IEC 17025Register refreshed 2026-09-25

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Scope items

Standards

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Register record

PCARefreshed 2026-09-25: AB 1763Active

Accredited standards

Our reading of the PCA 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.

ISO 10993 series

ISO 10993-3Biological evaluation of medical devices - Part 3: Evaluation of genotoxicity, carcinogenicity, reproductive toxicity and developmental toxicity

As written on the certificate · Line 2 (PCA AB 1763)

PN-EN ISO 10993-3:2014-12; PN-EN ISO 10993-4:2018-02; PN-EN ISO 10993-5:2009; PN-EN ISO 10993-23:2021-08; ISO 10993-10:2021; PN-EN ISO 10993-11:2018-08; PN-EN ISO 10993-6:2017-04; PN-EN ISO 11737 -1:2018-03; PN-EN ISO 11737 -1:2018-03 / A1:2021-11; PN-EN ISO 11737-2:2020; ISO 11737-3:2023

ISO 10993-4Biological evaluation of medical devices - Part 4: Selection of tests for interactions with blood

As written on the certificate · Line 2 (PCA AB 1763)

ISO 10993-5Biological evaluation of medical devices - Part 5: Tests for in vitro cytotoxicity

As written on the certificate · Line 2 (PCA AB 1763)

ISO 10993-6Biological evaluation of medical devices - Part 6: Tests for local effects after implantation

As written on the certificate · Line 2 (PCA AB 1763)

ISO 10993-7Biological evaluation of medical devices - Part 7: Ethylene oxide sterilization residuals

As written on the certificate · Line 3 (PCA AB 1763)

PN-EN ISO 10993-7:2009; PN-EN ISO 10993-18:2020-11; PN-EN ISO 10993-18:2020-11; PN-EN ISO 10993-18:2020-11

As written on the certificate · Line 4 (PCA AB 1763)

PN-EN ISO 10993-7:2009; PN-EN ISO 10993-18:2020-11; PN-EN ISO 10993-18:2020-11; PN-EN ISO 10993-18:2020-11; PN-EN ISO 10993-18:2020-11

ISO 10993-10Biological evaluation of medical devices - Part 10: Tests for skin sensitization

As written on the certificate · Line 2 (PCA AB 1763)

ISO 10993-11Biological evaluation of medical devices - Part 11: Tests for systemic toxicity

As written on the certificate · Line 2 (PCA AB 1763)

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 (PCA AB 1763)

PN-EN ISO 10993-7:2009; PN-EN ISO 10993-18:2020-11; PN-EN ISO 10993-18:2020-11; PN-EN ISO 10993-18:2020-11

As written on the certificate · Line 4 (PCA AB 1763)

PN-EN ISO 10993-7:2009; PN-EN ISO 10993-18:2020-11; PN-EN ISO 10993-18:2020-11; PN-EN ISO 10993-18:2020-11; PN-EN ISO 10993-18:2020-11

ISO 10993-23Biological evaluation of medical devices - Part 23: Tests for irritation

As written on the certificate · Line 2 (PCA AB 1763)

ISO 11737 series

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 (PCA AB 1763)

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 (PCA AB 1763)

ISO 11737-3Sterilization of health care products - Microbiological methods - Part 3: Bacterial endotoxin testing

As written on the certificate · Line 2 (PCA AB 1763)

Scope as published by PCA

4 lines

PCA

ISO/IEC 17025

Active

AB 1763

The scope document we hold says it is valid until 2028-11-08.

View on PCA

Accredited scope, certificate AB 1763

Line	Discipline	Method	Matrix	Range
1	biological; chemical	-	Medical devices	-
2	biological	PN-EN ISO 10993-3:2014-12; PN-EN ISO 10993-4:2018-02; PN-EN ISO 10993-5:2009; PN-EN ISO 10993-23:2021-08; ISO 10993-10:2021; PN-EN ISO 10993-11:2018-08; PN-EN ISO 10993-6:2017-04; PN-EN ISO 11737 -1:2018-03; PN-EN ISO 11737 -1:2018-03 / A1:2021-11; PN-EN ISO 11737-2:2020; ISO 11737-3:2023	-	-
3	chemical	PN-EN ISO 10993-7:2009; PN-EN ISO 10993-18:2020-11; PN-EN ISO 10993-18:2020-11; PN-EN ISO 10993-18:2020-11	-	1 to 60 mg/L
4	chemical	PN-EN ISO 10993-7:2009; PN-EN ISO 10993-18:2020-11; PN-EN ISO 10993-18:2020-11; PN-EN ISO 10993-18:2020-11; PN-EN ISO 10993-18:2020-11	-	1.2 to 3000 mas

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

ul. Nałkowskiej 5, Józefów, 05-410, PL

50.48083, 23.05406

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Accreditation data refreshed from the PCA register on 2026-09-25.

This page mirrors a public register. For a purchasing, audit or regulatory decision, confirm against the PCA entry linked above.