Foreword
Introduction
1 Scope
2 Normative references
3 Terms and definitions
4 General requirements
4.1 Safety for PEFMs that utilize electricity
4.2 Mechanical safety for all PEFMs
5 Identification, marking and documents
5.1 Marking of the scale or display
5.2 Marking of PEFM or packaging
5.3 Instructions for use
5.4 Technical description
6 PEFM measurement range
7 Performance requirements
7.1 Error of measurement
7.2 Linearity
7.3 Resistance to flow
7.4 Frequency response
8 Dismantling and reassembly
9 Effects of mechanical ageing
10 Effects of dropping a hand-held PEFM
11 Cleaning, sterilization and disinfection
11.1 Re-usable PEFM and parts
11.2 PEFM and parts delivered sterile
12 Compatibility with substances
13 Biocompatibility
Annex A (informative) Rationale for tests and examples of
test apparatus
Annex B (normative) Determination of error, repeatability and
resistance to PEFM output
Annex C (normative) Determination of frequency response
Annex D (normative) Test methods for determination of the effects
of dismantling, ageing and dropping
Annex E (informative) Environmental aspects
Annex F (informative) Reference to the essential principals
Annex ZA (informative) Relationship between this International
Standard and the Essential Requirements
of EU Directive 93/42/EEC
Bibliography