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EVS-ISO 35001:2020+A1:2024

Biorisk management for laboratories and other related organisations (ISO 35001:2019, identical + ISO 35001:2019/Amd 1:2024, identical)

General information

Valid from 15.10.2024
Base Documents
ISO 35001:2019; ISO 35001:2019/Amd 1:2024
ICS Groups
03.100.70 Management systems 07.100.01 Microbiology in general 11.100.01 Laboratory medicine in general
Directives or regulations
None

Standard history

Status
Date
Type
Name
15.10.2024
Main + amendment
EVS-ISO 35001:2020+A1:2024
15.10.2024
Amendment
EVS-ISO 35001:2020/A1:2024
02.06.2020
Main
EVS-ISO 35001:2020
This document defines a process to identify, assess, control, and monitor the risks associated with
hazardous biological materials. This document is applicable to any laboratory or other organization
that works with, stores, transports, and/or disposes of hazardous biological materials. This document
is intended to complement existing International Standards for laboratories.
This document is not intended for laboratories that test for the presence of microorganisms and/or
toxins in food or feedstuffs. This document is not intended for the management of risks from the use of
genetically modified crops in agriculture.

Required fields are indicated with *

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Standard monitoring
English (PDF 623 KB) Estonian (PDF 629 KB)

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Main + amendment

EVS-EN ISO 13485:2016+A11:2021

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Main

EVS-EN ISO 9001:2015 en

Quality management systems - Requirements (ISO 9001:2015)
Valid from 06.10.2015
Main + corrigendum

EVS-EN ISO 13485:2016

Medical devices - Quality management systems - Requirements for regulatory purposes (ISO 13485:2016)
Valid from 02.03.2016
Main

EVS-EN ISO 14001:2015

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Valid from 06.10.2015

Standards designation

EVS Estonian standard
EN European standard (published by an CEN or CENELEC)
EN ISO International standard adopted as an European standard
ISO International Organization for Standardization’s standard
IEC International Electrotechnical Commission’s standard
HD CENELEC’s harmonisation document
   
EVS-EN European standard implemented in Estonia
EVS-EN ISO International standard adopted in Europe and implemented in Estonia
EVS-EN ISO/IEC International standard/International electrotechnical standard adopted in Europe and implemented in Estonia
EVS-IEC International electrotechnical standard implemented in Estonia
EVS-ISO International standard implemented in Estonia
   
A, AMD amedment
+A a full standard plus the amendment
/A only amendment
COR, AC corrigendum
+COR a full standard plus the corrigendum
NA national annex
+NA a full standard plus the national annex
/NA only national annex
TS technical specification
TR technical report
CWA agreement, developed by a CEN or CENELEC
prEVS-EN (etc) draft standard
   
et the standard is in Estonian only
en the standard is in English only
et-en the standard is in Parallel text Estonian-English