SFS-EN ISO 81060-1:en

Soveltamisala

Suomenkielistä soveltamisalaa ei ole saatavissa.

ISO 81060-1:2007 specifies requirements for non-automated sphygmomanometers and their accessories, which, by means of inflatable cuffs, are used for the non-invasive blood pressure measurement by operator observation.
ISO 81060-1:2007 specifies requirements for the safety and essential performance, including effectiveness and labelling, for non-automated sphygmomanometers and their accessories, including test methods to determine the accuracy of non-invasive blood pressure measurement.
ISO 81060-1:2007 covers non-invasive blood pressure measurement devices with a pressure-sensing element and display used in conjunction with means of detecting blood flow.

Tämän julkaisun valmistelusta Suomessa vastaa Yhteinen Toimialaliitto, www.ytl.fi.

Sisällysluettelo

Foreword
Introduction
1 * Scope
2 Normative references
3 Terms and definitions
4 Identification and marking

4.1 * Units of measurement
4.2 * Legibility of markings
4.3 * Durability of markings
4.4 * Marking of non-automated sphygmomanometer
4.5 * Usability of reading
4.6 Marking of the cuff
4.7 Marking of the non-automated sphygmomanometer packaging

5 General requirements for testing non-automated sphygmomanometers

5.1 * Type tests
5.2 * Representative sample
5.3 Environmental conditions
5.4 Repairs and modifications
5.5 * Humidity preconditioning treatment

6 General requirements

6.1 General
6.2 Electrical safety
6.3 Mechanical safety
6.4 Mechanical strength

7 Requirements

7.1 Pressure indicating means
7.2 Pneumatic system
7.3 * Tamper proofing or unauthorized access
7.4 Dynamic response in normal use

8 Additional requirements for non-automated sphygmomanometer with mercury manometer

8.1 * Internal diameter of the tube containing mercury
8.2 * Portable non-automated sphygmomanometer
8.3 * Prevention of mercury spillage during transport
8.4 * Prevention of mercury spillage in normal use
8.5 Quality of the mercury

9 Non-automated sphygmomanometers with aneroid manometer

9.1 * Scale mark at zero
9.2 * Zero
9.3 Hysteresis error
9.4 * Construction and materials

10 Cleaning, sterilization and disinfection

10.1 Reusable non-automated sphygmomanometer and parts
10.2 Non-automated sphygmomanometer and parts requiring processing before use
10.3 Non-automated sphygmomanometer and parts delivered sterile

11 Biocompatibility
12 Information supplied by the manufacturer

12.1 Accompanying document
12.2 Instructions for use
12.3 Technical description

Annex A Rationale and guidance (informative)
Annex B Advice regarding non-automated sphygmomanometers with a mercury manometer (informative)
Annex C Environmental aspects (informative)
Annex D Reference to the essential principals (informative)
Annex E Terminology — Alphabetized index of defined terms (informative)

Bibliography

Näytä kaikki

Foreword
Introduction
1 * Scope
2 Normative references
3 Terms and definitions
4 Identification and marking

4.1 * Units of measurement
4.2 * Legibility of markings
4.3 * Durability of markings
4.4 * Marking of non-automated sphygmomanometer
4.5 * Usability of reading
4.6 Marking of the cuff
4.7 Marking of the non-automated sphygmomanometer packaging

5 General requirements for testing non-automated sphygmomanometers

5.1 * Type tests
5.2 * Representative sample
5.3 Environmental conditions
5.4 Repairs and modifications
5.5 * Humidity preconditioning treatment

6 General requirements

6.1 General
6.2 Electrical safety
6.3 Mechanical safety
6.4 Mechanical strength

7 Requirements

7.1 Pressure indicating means
7.2 Pneumatic system
7.3 * Tamper proofing or unauthorized access
7.4 Dynamic response in normal use

8 Additional requirements for non-automated sphygmomanometer with mercury manometer

8.1 * Internal diameter of the tube containing mercury
8.2 * Portable non-automated sphygmomanometer
8.3 * Prevention of mercury spillage during transport
8.4 * Prevention of mercury spillage in normal use
8.5 Quality of the mercury

9 Non-automated sphygmomanometers with aneroid manometer

9.1 * Scale mark at zero
9.2 * Zero
9.3 Hysteresis error
9.4 * Construction and materials

10 Cleaning, sterilization and disinfection

10.1 Reusable non-automated sphygmomanometer and parts
10.2 Non-automated sphygmomanometer and parts requiring processing before use
10.3 Non-automated sphygmomanometer and parts delivered sterile

11 Biocompatibility
12 Information supplied by the manufacturer

12.1 Accompanying document
12.2 Instructions for use
12.3 Technical description

Annex A Rationale and guidance (informative)
Annex B Advice regarding non-automated sphygmomanometers with a mercury manometer (informative)
Annex C Environmental aspects (informative)
Annex D Reference to the essential principals (informative)
Annex E Terminology — Alphabetized index of defined terms (informative)

Bibliography

Tuoteryhmä(t)

11.040.10 Anestesia-, hengitys- ja elvytyskoneet »

Sidokset

Velvoittavat viittaukset

IEC 60601-1:2005
ISO 10993-1:2009 Biological evaluation of medical devices -- Part 1: Evaluation and testing within a risk management process
ISO 14937:2009 Sterilization of health care products -- General requirements for characterization of a sterilizing agent and the development, validation and routine control of a sterilization process for medical devices

Tekninen komitea

CEN/TC 205 Non-active medical devices »

Direktiivi

93/42/EEC Lääkinnälliset laitteet

http://ec.europa.eu »

Vahvistuspäivä

03.09.2012

Julkaisupäivä

21.09.2012

Painos

1

Sivumäärä

45

Julkaisun kieli

englanti