ONORM EN ISO 17510-1 : 2009

Foreword
Introduction
Section one - General
            1 Scope
            2 Normative references
            3 Terms and definitions
            4 General requirements and general requirements
               for test
            5 Classification
            6 Identification, marking and documents
            7 Power input
Section two - Environmental conditions
            8 Basic safety categories
            9 Removable protective means
            10 Environmental conditions
            11 Not used
            12 Not used
Section three - Protection against electric shock hazards
            13 General
            14 Requirements related to classification
            15 Limitation of voltage and/or energy
16 Enclosures and protective covers
            17 Separation
            18 Protective earthing, functional earthing
               and potential equalization
            19 Continuous leakage currents and patient
               auxiliary currents
            20 Dielectric strength
Section four - Protection against mechanical hazards
            21 Mechanical strength
            22 Moving parts
            23 Surfaces, corners and edges
            24 Stability in normal use
            25 Expelled parts
            26 Vibration and noise
            27 Pneumatic and hydraulic power
            28 Suspended masses
Section five - Protection against hazards from unwanted
               or excessive radiation
            29 X-radiation
            30 Alpha, beta, gamma, neutron radiation and other
particle radiation
            31 Microwave radiation
            32 Light radiation (including lasers)
            33 Infra-red radiation
            34 Ultra-violet radiation
            35 Acoustical energy (including ultra-sonics)
            36 Electromagnetic compatibility
Section six - Protection against hazards of ignition of
              flammable anaesthetic mixtures
            37 Locations and basic requirements
            38 Marking, accompanying documents
            39 Common requirements for Category AP and category
               APG equipment
            40 Requirements and tests for category AP equipment,
               parts and components thereof
            41 Requirements and tests for category APG equipment,
               parts and components thereof
Section seven - Protection against excessive temperatures and other
                safety hazards
            42 Excessive temperatures
            43 Fire prevention
            44 Overflow, spillage, leakage, humidity, ingress
               of liquids, cleaning, sterilization and disinfections
            45 Pressure vessels and parts subject to pressure
            46 Not used
            47 Electrostatic charges
            48 Biocompatibility
            49 Interruption of the power supply
Section eight - Accuracy of operating data and protection
                against hazardous output
            50 Accuracy of operating data
            51 Protection against hazardous output
Section nine - Abnormal operation and fault conditions;
               environmental tests
            52 Abnormal operation and fault conditions
            53 Environmental tests
Section ten - Constructional requirements
            54 General
            55 Enclosures and covers
            56 Components and general assembly
            57 Main parts, components and layout
            58 Protective earthing - terminals and connections
            59 Construction and layout
Annexes
       Annex AA (informative) Rationale
       Annex BB (informative) Glossary
       Annex ZA (informative) Clauses of this European standard
                addressing essential requirements or other
                provisions of EU directives
       Annex ZB (normative) Normative references to international
                publications with their relevant European
                publications
Bibliography

Describes requirements for equipment intended for sleep apnoea breathing therapy for domiciliary use, ships, aircraft and other transport vehicles and for use in healthcare institutions.