SFS-EN ISO 17099:2017:en

Soveltamisala

Suomenkielistä soveltamisalaa ei ole saatavissa.

ISO 17099:2014 addresses the following:
a) confidentiality of personal information for the customer and the laboratory;
b) laboratory safety requirements;
c) radiation sources, dose rates, and ranges used for establishing the calibration reference dose-effect curves allowing the dose estimation from CBMN assay yields and the minimum resolvable dose;
d) performance of blood collection, culturing, harvesting, and sample preparation for CBMN assay scoring;
e) scoring criteria;
f) conversion of micronucleus frequency in binucleated cells into an estimate of absorbed dose;
g) reporting of results;
h) quality assurance and quality control;
i) informative annexes containing examples of a questionnaire, instructions for customers, a microscope scoring data sheet, a sample report and advice on strengths and limitations of current automated systems for automated micronucleus scoring.

Tämän julkaisun valmistelusta Suomessa vastaa Metalliteollisuuden Standardisointiyhdistys ry, puh. 09 19 231 (vaihde).

Sisällysluettelo

Foreword
Introduction
1 Scope
2 Terms and definitions
3 Micronucleus assay methodology used in this standard

3.1 General
3.2 General requirement of the laboratory
3.3 Requests for analysis and blood sampling
3.4 Cell culturing
3.5 Staining
3.6 Microscopy
3.7 Visual scoring of slides
3.8 Automated analysis

4 Confidentiality of personal information

4.1 Overview
4.2 Applications of the principle of confidentiality

5 Laboratory safety requirements

5.1 Overview
5.2 Microbiological safety requirements
5.3 Chemical safety requirements
5.4 Optical safety requirements
5.5 Safety plan

6 Calibration source(s), calibration curve, and minimum resolvable dose

6.1 Calibration source(s)
6.2 Calibration curve
6.3 Background micronucleus frequency
6.4 Minimum resolvable dose measurement

7 Responsibility of the customer
8 Responsibility of the CBMN laboratory

8.1 Setup and sustainment of the QA program
8.2 Responsibility during service

9 Accidental overexposure involving few individuals

9.1 Procedure for scoring micronuclei in binucleated cells
9.2 Criteria for converting a micronucleus yield into an estimate of absorbed dose
9.3 Reporting of Results

10 Population triage

10.1 General
10.2 Use of a CBMN assay network for large scale exposures
10.3 Procedure for scoring micronuclei in binucleated cells
10.4 Criteria for converting a micronucleus yield into an estimate of absorbed dose
10.5 Reporting of results

11 Quality assurance and quality control

11.1 Overview
11.2 Quality Assurance
11.3 Quality control

Annex A Sample data sheet for recording micronuclei in binucleated cells (informative)
Annex B Automation of micronuclei scoring (informative)
Annex C Instructions for customer (sample) (informative)
Annex D Sample questionnaire (informative)
Annex E Sample of report for single assessment (informative)
Annex F Example group sample report (informative)

Bibliography

Näytä kaikki

Foreword
Introduction
1 Scope
2 Terms and definitions
3 Micronucleus assay methodology used in this standard

3.1 General
3.2 General requirement of the laboratory
3.3 Requests for analysis and blood sampling
3.4 Cell culturing
3.5 Staining
3.6 Microscopy
3.7 Visual scoring of slides
3.8 Automated analysis

4 Confidentiality of personal information

4.1 Overview
4.2 Applications of the principle of confidentiality

5 Laboratory safety requirements

5.1 Overview
5.2 Microbiological safety requirements
5.3 Chemical safety requirements
5.4 Optical safety requirements
5.5 Safety plan

6 Calibration source(s), calibration curve, and minimum resolvable dose

6.1 Calibration source(s)
6.2 Calibration curve
6.3 Background micronucleus frequency
6.4 Minimum resolvable dose measurement

7 Responsibility of the customer
8 Responsibility of the CBMN laboratory

8.1 Setup and sustainment of the QA program
8.2 Responsibility during service

9 Accidental overexposure involving few individuals

9.1 Procedure for scoring micronuclei in binucleated cells
9.2 Criteria for converting a micronucleus yield into an estimate of absorbed dose
9.3 Reporting of Results

10 Population triage

10.1 General
10.2 Use of a CBMN assay network for large scale exposures
10.3 Procedure for scoring micronuclei in binucleated cells
10.4 Criteria for converting a micronucleus yield into an estimate of absorbed dose
10.5 Reporting of results

11 Quality assurance and quality control

11.1 Overview
11.2 Quality Assurance
11.3 Quality control

Annex A Sample data sheet for recording micronuclei in binucleated cells (informative)
Annex B Automation of micronuclei scoring (informative)
Annex C Instructions for customer (sample) (informative)
Annex D Sample questionnaire (informative)
Annex E Sample of report for single assessment (informative)
Annex F Example group sample report (informative)

Bibliography

Tuoteryhmä(t)

13.280 Säteilyltä suojautuminen »

Sidokset

Velvoittavat viittaukset

Tässä julkaisussa ei ole velvoittavia viittauksia

Tekninen komitea

CEN/TC 430 Nuclear energy, nuclear technologies, and radiological protection »

Vahvistuspäivä

20.10.2017

Julkaisupäivä

24.10.2017

Painos

1

Sivumäärä

39

Julkaisun kieli

englanti