ISO/TC276 &CULTURE

COLLECTIONS

Li Xian

Institute of Microbiology,

Chinese Academy of Sciences

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CONTENTS

Overview of relations between

standardization and development of

culture collections

Introduction to ISO techinical

committe 276 -Biotechnology

General rules and procedures of ISOstandard development

Standards Improve Global Connectivity

International Standards give world-class specifications for products, services and

systems, to ensure quality, safety and efficiency. They are instrumental in facilitating

international trade.

——Standards have become the common language of the world.

WDCM Reference Strain Catalogue-

WDCM Refstrain Catalogue was initially

produced to enable broader and easier access

to the reference strains listed by the ISO TC

34 SC 9 Joint Working Group 5 (Food

microbiology - Culture media) in the ISO

11133 standard and by the ICFMH-WPCM

in Handbook of Culture Media for Food

and Water Microbiology.

It helps users find local sources of the

reference strains by citing all collections that

contain them and providing contact details

and the collection's unique reference.

Up to now, WDCM Refstrain database has covered 65 standards, including 29

international standards (24 ISO standards, 5 IDF standards), 9 EU standards and 27

national standards.

Contents Page

Foreword iv

Introduction v

1. Scope 1

2. Normative reference 1

3. Terms and definitions 1

4. Principle 2

5. Safety precaution 2

6. Reference fungi 3

7. Apparatus 3

8. Reagents and culture media 5

9. Fungus preservation and use 8

10. Spore suspension 9

11. Preparing ATP calibration curve 12

12. Testing method 13

13. Measurement of luminescence

intensity 15

14. Calculation 17

15. Test report 18

Annex A 19

Annex B 20

Bibliography 21

e.g. Antifungal activity testing method

ISO/FDIS 13629-1

ISO/FDIS 13629-1 Antifungal activity testing method

WDCM number Species Preservation No.

00144 Aspergillus niger

ATCC 6275UMIP 2475.98DSM 1957NBRC 105649

00189Penicilliumcitrinum

ATCC 9849NBRC 6352

00190Cladosporiumcladosporioides

ATCC 11277NBRC 6368NBRC 6348

00191Trichophytonmentagrophytes

NBRC 32409NBRC 32412

The utilization of WDCM reference strains according to ISO standards

count total

Food manufacture and security 25Milk and milk products 55 157Microbiology of food and animal feeding stuffs 77Biological evaluation of medical devices 2Dentistry 1Washer-disinfectors 12Sterilization of health care products 26Surgical drapes, gowns and clean air suits, used as medical devices 6 99Retrieval and analysis of surgical implants 1Optics and optical instrument 10Medical laboratories 5Clinical laboratory testing and in vitro diagnostic test systems 28Modification of the isolation media and the haemolysis test 6Cleanrooms and associated controlled environments 2Water quality 57 57Textiles 10Lubricants, industrial oils and related products 3

Chemical analysis of refractory products by XRF 1 32

Plastics 17Safety of machinery 1Cosmetics 22 22Indoor air 11Soil quality 4 15

26%

4%41%

15%

8%6%

medical devices and health

environments

Foodstuffs

Water quality

industrial production

Cosmetics

WDCM Reference Strain Catalogue

Quality control and ISO Standards Accreditions

ISO/IEC 17025

ISO 9001Quality Management System (QMS) standard that can benefit organization of

any size .

ISO 15189Medical laboratories -- Requirements for quality and competence

Comparison of Quality Standards

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CONTENTS

Overview of relations between

standardization and development of

culture collections

Introduction to ISO techinical

committe 276 -Biotechnology

General rules and procedures of ISOstandard development

General rules of ISO standard development

An ISO standard is developed by a panel of experts, within a technical committee. Once the need for a standard has been established, these experts meet to discuss and negotiate a draft standard. As soon as a draft has been developed it is shared with ISO's members who are asked to comment and vote on it. If a consensus is reached the draft becomes an ISO standard, if not it goes back to the TC for further edits.

Key principles

ISO (International Organization for Standardization) standards:

-respond to a need in the market;

-are based on global expert opinion;

-are developed through a multi-stakeholder process;

-are based on global consensus.

ISO and developing countries

Over three quarters of 163 ISO members from developing countries. So increasing the participation of developing country members and strengthening their standardization infrastructures is an ISO priority.

Twinning arrangements:

A developing country member may enter into an arrangement with a developed country member that is in a position to share its knowledge. A twinning relationship means that members can work together to build capacity of a developing country.

DEVCO is the Committee on developing country matters and is a forum for developed and developing countries to exchange views. DEVCO members meet annually.

Award for young standardizers in developing countries:

Sponsored by DIN, the German Institute for Standardization, ISO's award for youngprofessionals in developing countries working for national standards bodies is awardedevery two years and aims to encourage engagement by young people in internationalstandardization and raise awareness of the importance of standards in promoting safeand sustainable economic development. Entries are now being accepted.

ISO Membership-The rights and obligations

ISO is a network of 164 national standards bodies (NSBs) who make up the ISO membership and represent ISO in their country.

ISO Membership---The rights and obligations

• ISO is a network of national standards bodies (NSB) which make upthe ISO membership. These bodies represent ISO in their countries.

• ISO has one member per country, eg. Brazil (ABNT), India (BIS), Iran(ISIRI) , Nigeria (SON), Tanzania(TBS) and etc.

• ISO’s full members ( member bodies) can decide if they would liketo be a participating member (P-member) of a particular TC/SC(technical committees or subcommittees )or an observing member(O-member).

• P-members participate actively in the work and have an obligationto vote on all questions submitted to vote within the technicalcommittee.

• O-members follow the work as observers; they receive committeedocuments and have the right to submit comments and to attendmeetings, but cannot vote.

Liason

Agreement which might be between two ISO committees, an ISO committee and a corresponding IEC committee or an ISO committee and an external organization where they share expertise and relevant documents. There are different categories of external liaison with varying eligibility criteria but all must be non-profit.

A Liason: committee level

D Liason: working group level

General principles for counting votes

• For votes by correspondence or during a committee meeting, a simple majority of the P-members voting is required for approval unless otherwise specified in the ISO/IEC Directives.

• The committee leadership shall ensure that votes submitted in writing, in advance of a committee meeting, are considered at the meeting.

• In all votes throughout the various stages of development of a deliverable, abstentions are not counted.

• Proxy voting is not permitted in ISO, except in P-member twinning arrangements.

• Working group level decisions: one expert = one voice Committee level decisions: one country = one vote

How to develop ISO standards

ISO/IEC Directives Part 1 and Consolidated ISO Supplement, 7th

edition , 2016English, French &Russian versions of the related ISO documents are

available on the following website :http://isotc.iso.org/livelink/livelink?func=ll&objId=4230450&objAction=browse&sort=name&viewType=1

ISO deliverables

ISO develops the following deliverables:ISO Standards, ISO/PAS Publicly Available Specifications, ISO/TS Technical Specifications, ISO/TR Technical Reports, IWA International Workshop Agreements and ISO Guides

0 Preliminary stage (PWI)

All PWIs(preliminary work items) shall be registered into the programme of work, by a simple majority vote of their P-members of TC/SC.

The committee shall evaluate the market relevance and resources required for all the PWIs.

No target dates can be established for PWIs.

1 Proposal stage (NP)A new work item proposal (NWIP, NP) is submitted to the committee for vote using Form 4. The electronic balloting portal should be used for the vote.The proposers of the new work item proposal shall— make every effort to provide a first working draft for discussion, or shall at least provide an outline of such a working draft;— nominate a project leader.This stage can be skipped for revisions and amendments to ISO standards that are already published.

Acceptance requiresa) approval of the work item by a simple majority of the P-members of the TC/SC voting —

abstentions are excluded when the votes are counted; andb) a commitment to participate actively in the development of the project, i.e. to make an effective contribution at the preparatory stage, by nominating technical experts and by commenting on working drafts . For TC276, a proposal will be approved with at least 5 P-members’ commitment to participate actively ;

ISO Project Stages

2 Preparatory stage (WD)

• The preparatory stage covers the preparation of a workingdraft (WD) conforming to the ISO/IEC Directives, Part 2.

• When a new project is accepted the project leader shall work with the experts nominated by the P-members during the approval(active participating member bodies). Other P-members or A- or D- liaison organizations may also nominate expert(s).

• The secretariat may propose to the TC/SC to create a working group or project team, and the TC/SC shall define the target date(s) for submission of draft(s).

• Successive WD can be circulated until the experts are satisfied that they have developed the best solution they can. The draft is then forwarded to the working group’s parent committee who will decide which stage to go to next (Committee stage or Enquiry stage).

eCommittees platform can be used for sharing documents at this and other stages of standards development.

3 Committee stage (CD)

• The committee stage is the principal stage at which comments from national bodies are taken into consideration, with a view to reaching consensus on the technical content.

• consensus: General agreement, characterized by the absence of sustained opposition to substantial issues by any important part of the concerned interests and by a process that involves seeking to take into account the views of all parties concerned and to reconcile any conflicting arguments. Consensus need not imply unanimity.

• The period default for CD circulation is 8 weeks.

• The committee stage ends when all technical issues have been resolved and a committee draft is accepted for circulation as an enquiry draft and is registered by the office of the CEO.

4 Enquiry stage(DIS)

The Draft International Standard (DIS) is submitted to ISO Central Secretariat by the committee secretary. It is then circulated to all ISO members who get 3 months to vote and comment on it.

• The DIS is approved if a two-thirds of the ISO P-members are in favor and not more than one-quarter of the total number of votes cast are negative

• If the DIS is approved the project goes straight to publication. However, the committee leadership can decide to include the FDIS stage if needed.

01

02

03

CONTENTS

Overview of relations between

standardization and development of

culture collections

Introduction to ISO techinical

committe 276 -Biotechnology

General rules and procedures of ISOstandard development

ISO TC 276 BIOTECHNOLOGY

Creation date: 2013

Secretariat: DIN

Participating Countries：25

Observing Countries：14

WG Title Convener /Co-convener

WG1 Terminology Dr. Pablo Serrano (DE)

WG2 Biobanks and bioresources Dr. Georges Dagher (FR)/ Yong Zhang (CN)

WG3 Analytical methods Dr. Sheng Lin Gibson (US)

WG4 Bioprocessing Tatsuo Heki (JP)

WG5 Data processing and integration

Martin Golebiewski (DE)/ Yong Zhang (CN)

Participating Countries Culture collections

Argentina (IRAM) Dmic,BGIV, BNM, CEP

Austria (ASI) ACBR

Belgium (NBN) BCCM/MUCL, BCCM/LMG, BCCM/LMBP, BCCM/IHEM, BCCM/ULC, ITM, BCCM/DCG

Brazil (ABNT) Fiocruz-CLIOC, CEMM, CCT, IAL, CLEV

Canada (SCC) CPCC, CPVC

China (SAC) CGMCC, FACHB, CICC, JMCC, HCCCM, CPCC, CMCC, ACCC, GDMCC, CCTCC, BCRC

France (AFNOR) CIP, CIRM-CFBP, CIRM-Levures, CIRM-CF, TCC, CIRM-BP

Germany (DIN) DSMZ, CCCryo, JMRC

Iran (ISIRI) IBRC, PTCCI

Italy (UNI) BVR, DBVPG, MUT

Japan (JISC) JCM, NBRC

Korea, Republic of (KATS) KCTC,CCARM, HPKTCC, KEMB, KMMCC, LEF, PVGB

Netherlands (NEN) CBS

Portugal (IPQ) UMinho-MUM, ACOI

Sri Lanka (SLSI) RRISLCC

United Kingdom (BSI) IMI(CABI), CCAP, NCTC, ECACC, NCPV, NCPF

United States (ANSI) FGSC, UCDFST, TMC, UTEX, NCMA

ISO/TC 276 Participating Countries

67 culture collections from 17 of 25 Participating Countries (P members) of ISO/ TC 276 have registered in WFCC.

Participation in the ISO/TC 276

Participating Countries (25) ----P members

Argentina (IRAM), Australia (SA) , Austria (ASI), Belgium (NBN) , Brazil (ABNT) , Canada (SCC) , China (SAC) , Denmark (DS) , Finland (SFS), France (AFNOR) , Germany (DIN) , Iran, Islamic Republic of (ISIRI) , Ireland (NSAI), Israel (SII) , Italy(UNI), Japan (JISC), Korea, Republic of (KATS) , Luxembourg (ILNAS), Nigeria (SON), Portugal (IPQ) , Sri Lanka (SLSI), Sweden (SIS), Tanzania, United Republic of (TBS) , United Kingdom (BSI), United States (ANSI)

Observing Countries (14)----O members

Colombia (ICONTEC), Czech Republic (UNMZ), Ecuador (INEN), Estonia (EVS), Hungary (MSZT), India (BIS) , Lithuania (LST), Mexico (DGN), Mongolia (MASM) , Netherlands (NEN), Norway (SN), Poland (PKN), Spain (AENOR), Switzerland (SNV)

ISO/ TC 276 Work Programme

20.60 Preparatory Stage Close of comment period

20.00 Preparatory Stage New project registered in TC/SC work programme

ISO/TC 276 Work Programme

Project Title WG Proposer

Cell Counting -- Part 1: General guidance on cell counting methods (WD 20391-1)

3Dr. Sheng Lin-Gibson

(US)

Cell Counting -- Part 2: Experimental design and statistical analysis to quantify counting method performance(WD20391-2)

3Dr. Sheng Lin-Gibson

(US)

Raw materials control for bioprocessing -- Part 1: General definitions and requirements for quality control（AWI TS 20399-1）

4 Tatsuo Heki (JP)

Raw materials control for bioprocessing -- Part 2: Best practice guide for supplies（AWI TS 20399-2）

4Jiwen Zhang (US)

Raw materials control for bioprocessing -- Part 3: Best practice guide for developers（AWI TS 20399-3 ）

4Nicholas Medcalf (BE)

Quality considerations for targeted nucleic acid quantification methods（AWI 20395）

3 Helen Parkes (BE)

Project Title WG Proposer

Terms & Definitions-Inventory development (PWI 20386) 1 Dr. Pablo Serrano (DE)

Biobanking-general requirements for biobanks(PWI 20387&PWI 20390）

2 Dr. Georges Dagher (FR)

Collection, processing, storage and transportation technology criteria for animal germplasm （PWI 20388）

2 Yong Zhang (CN)

Collection, processing, conserving and trans-portation criteria for humangenetic resources （PWI 20389）

2 Dr. Xiaomin Wang (CN)

Methods to determine the concentration of total nucleic acids（PWI 20396）

3 Dr. Fay Betsou (BE)

Method to evaluate the quality of massive sequencing data（PWI 20397）

3 Yong Zhang (CN)

General definitions and requirements for the production and quality control of synthetic nucleic acids （PWI 20688）

3 Hiroki nakae (JP)

Methods to control bioreactor process for cell culturing（PWI 20398）

4 Tatsuo Heki (JP)

Downstream data processing and integration workflows（PWI 20691）

5 Martin Golebiewski (DE)

Microbial resources data-specification on datamanagement and publication in microbial resources centre（PWI 21710）

5 Dr. Juncai Ma (CN)

11 projects in preliminary stage were registered in ISO/TC 276

Working Group 2 Biobanks and Bioresources

MRC related standards in WG2

• Biotechnology — Biobanking — General requirementsfor Biobanks

• General requirements for the validation and verification of bioprocessing methods in biobanks

Working Group 5 Establishedat ISO/TC 276 plenary meeting in Shenzhen(China) on April 17, 2015 (upon request by the German delegation of ISO/TC 276 Biotechnolgy). WG5 aims to develop standards for traceable, searchable, and interoperable data together with integrated data processing for biotechnology and life sciences.The main foci are:- definition of data and model formats and their interfaces;- definition of metadata and relations of data and models;- quality management of processed data and models.

2015

07

2016

10

ISO/TC276

2015

03

2015

04

2015

09

2015

10

2016

05

1st WG5

meeting

Berlin

2nd WG5

meeting

Tokyo

4th WG5

meeting

Washington

3 rd ISO/TC

276 plenary

meeting

Shenzhen

Establishment

of WG 5

3rd WG5

meeting

Paris

WG5

ad-hoc

meeting

(WebEx)

2015

01

N60

N84

5th WG5

meeting

Dublin

2015

03

ISO/TC 276 WG5 Data Processing and Integration

Participating: Currently about 50 Experts from 13

Countries(P-Member):

China(SAC), France (AFNOR), Germany (DIN), Great

Britain(BSI), Iran(ISIRI), Ireland(NSAI), Japan(JISC),

Luxembourg (ILNAS), Republic of Korea (KATS), United

States (ANSI) and

NEW:Argentina (IRAM), Canada(SCC), Israel(SII)

Liaison: - BBMRI-ERIC (Biobanking and BioMolecular

resources Research Infrastructure European Research

Infrastructure Consortium)

- ISO/IEC JTC 1/SC 29/WG 11 (MPEG): strategic alliance

with ISO/TC 276 WG5 to developa “Genome Compression

Standard“ together

ISO/TC 276 WG5 MEETING 10-11 MAY 2016, WASHINGTON DC (USA)

Biotechnology-Microbial resources data—

specification on data management and

publication in microbial resources centre

PWI 21710Potential users: Culture collections, Research groups and Biotechnology companies in the field of microbiology .

JCM NBRC CBS DSMZ

WDCM Recommended datasets

Biochemistry

package

Environment

package

Application

package

Sequences information

package

Data format diversity in different culture collections

Status of the project

Presentation of the microbial standard proposal in ISO/TC 276 WG2 Tokyo meeting

by Dr Ma. (2015.10)

New work item proposal (Form 4) and draft outline were submitted to ISO/TC

276/WG 5 and circulated as N 84 file among TC 276 members. (2016.4)

Presentation of the microbial standard proposal in ISO/TC 276 WG5 Washington

meeting by Dr Ma.(2016.5)

Recommendation 10/2016/01 on 2016-05-11 (WG 5 N 103 ): WG 5 agrees to

register the proposal as a PWI (PWI 21710) and requires experts from WG 2 should

be involved in this preparatory work.

With suggestions and comments collected in WDCM, we will complete the first draft.

The NWIP (New work item proposal) documents will be submitted to TC 276 for CIB (Committee internal ballot).

Thanks for your attentions!

Li Xian

lixian@im.ac.cn