SIST EN ISO 15002:2008/oprA2:2020
(Amendment)Flow-metering devices for connection to terminal units of medical gas pipeline systems - Amendment 2 (ISO 15002:2008/DAM 2:2020)
Durchflussmesseinrichtungen zum Anschluss an Entnahmestellen von Rohrleitungssystemen für medizinische Gase (ISO 15002:2008/DAM 2:2020)
Dispositifs de mesure de débit pour raccordement aux prises murales des systèmes de distribution de gaz médicaux - Amendement 2 (ISO 15002:2008/DAM 2:2020)
Pretočni merilniki za priključitev na končne dele napeljav za medicinske pline - Dopolnilo A2 (ISO 15002:2008/DAM 2:2020)
General Information
- Status
- Not Published
- Public Enquiry End Date
- 19-Jan-2020
- Technical Committee
- VAZ - Healthcare
- Current Stage
- 4020 - Public enquire (PE) (Adopted Project)
- Start Date
- 28-Jan-2020
- Due Date
- 16-Jun-2020
- Completion Date
- 01-Apr-2020
- Directive
- Not Harmonized93/42/EEC - Medical devices
Relations
- Effective Date
- 01-Mar-2020
Overview
SIST EN ISO 15002:2008/oprA2:2020 specifies the requirements and amendments for flow-metering devices connected to terminal units of medical gas pipeline systems. This amendment (Amendment 2 to ISO 15002:2008) focuses on safety-critical changes, especially regarding the marking and operational controls of flow-meters used in medical environments such as hospitals and clinics. The amendment is essential for manufacturers, healthcare facilities, and regulatory authorities to ensure safe and compliant delivery of medical gases.
Key Topics
Flow-metering Device Marking
All flow-metering devices capable of supplying flows greater than those indicated on the scale must be clearly marked with the maximum flow deliverable at the specified pipeline pressure. This requirement improves user awareness and supports safe clinical practice.Operational Safety for Flowmeters
The amendment revises previous limits on maximum flow when the device’s control valve is fully open. Instead of restricting the maximum flow, it mandates clear marking and visual inspection to verify compliance.Scale and Accuracy
Additions to scale requirements ensure that any adjustable flow control device has a clearly indicated maximum deliverable flow, supporting safe usage, especially where high flows may be dangerous, such as with neonatal and paediatric patients.Functional Positioning and Safety Controls
The amendment requires flow controls for multiple orifice metering devices to be designed so that:- They cannot be left between settings with no flow.
- It is not possible to exceed the maximum setting.
- Deliveries between adjacent flow settings do not exceed 150% of the higher setting. Compliance is checked via functional testing.
Supporting Documentation
Manufacturers must clearly state the maximum flow delivered and the pressure for this flow in technical documentation.
Applications
The amended standard applies broadly in the medical gas supply sector, especially in:
Hospitals and Critical Care Facilities Where precise and safe delivery of medical gases is vital for patient safety, particularly in anesthesia, intensive care, and pediatric wards.
Manufacturing and Procurement For medical device manufacturers and equipment procurement divisions to ensure that products meet current international safety and performance requirements.
Regulatory Compliance National and regional regulatory bodies reference this standard for healthcare facility inspections and market approvals.
Healthcare Staff Training Providing clinical personnel with clear, consistent information about the capabilities and safe use of flow-metering devices.
Related Standards
To ensure holistic compliance and interoperability within medical gas pipeline systems, the following standards are closely related:
EN ISO 7396-1
Medical gas pipeline systems - Part 1: Pipeline systems for compressed medical gases and vacuumISO 9170-1
Terminal units for medical gas pipeline systems - General requirementsISO 11135
Sterilization of health-care products - Requirements for medical devices
These standards collectively support a robust safety framework for medical gas delivery and equipment compatibility.
Keywords: flow-metering devices, medical gas pipeline systems, medical gas safety, flowmeter standards, medical device marking, patient safety, hospital gas systems, SIST EN ISO 15002, ISO 15002:2008 Amendment 2, healthcare equipment compliance
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Frequently Asked Questions
SIST EN ISO 15002:2008/oprA2:2020 is a draft published by the Slovenian Institute for Standardization (SIST). Its full title is "Flow-metering devices for connection to terminal units of medical gas pipeline systems - Amendment 2 (ISO 15002:2008/DAM 2:2020)". This standard covers: Flow-metering devices for connection to terminal units of medical gas pipeline systems - Amendment 2 (ISO 15002:2008/DAM 2:2020)
Flow-metering devices for connection to terminal units of medical gas pipeline systems - Amendment 2 (ISO 15002:2008/DAM 2:2020)
SIST EN ISO 15002:2008/oprA2:2020 is classified under the following ICS (International Classification for Standards) categories: 11.040.10 - Anaesthetic, respiratory and reanimation equipment. The ICS classification helps identify the subject area and facilitates finding related standards.
SIST EN ISO 15002:2008/oprA2:2020 has the following relationships with other standards: It is inter standard links to SIST EN ISO 15002:2008. Understanding these relationships helps ensure you are using the most current and applicable version of the standard.
SIST EN ISO 15002:2008/oprA2:2020 is associated with the following European legislation: EU Directives/Regulations: 93/42/EEC; Standardization Mandates: M/023. When a standard is cited in the Official Journal of the European Union, products manufactured in conformity with it benefit from a presumption of conformity with the essential requirements of the corresponding EU directive or regulation.
SIST EN ISO 15002:2008/oprA2:2020 is available in PDF format for immediate download after purchase. The document can be added to your cart and obtained through the secure checkout process. Digital delivery ensures instant access to the complete standard document.
Standards Content (Sample)
SLOVENSKI STANDARD
01-marec-2020
Pretočni merilniki za priključitev na končne dele napeljav za medicinske pline -
Dopolnilo A2 (ISO 15002:2008/DAM 2:2020)
Flow-metering devices for connection to terminal units of medical gas pipeline systems -
Amendment 2 (ISO 15002:2008/DAM 2:2020)
Durchflussmesseinrichtungen zum Anschluss an Entnahmestellen von
Rohrleitungssystemen für medizinische Gase (ISO 15002:2008/DAM 2:2020)
Dispositifs de mesure de débit pour raccordement aux prises murales des systèmes de
distribution de gaz médicaux - Amendement 2 (ISO 15002:2008/DAM 2:2020)
Ta slovenski standard je istoveten z: EN ISO 15002:2008/prA2
ICS:
11.040.10 Anestezijska, respiratorna in Anaesthetic, respiratory and
reanimacijska oprema reanimation equipment
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.
DRAFT AMENDMENT
ISO 15002:2008/DAM 2
ISO/TC 121/SC 6 Secretariat: ANSI
Voting begins on: Voting terminates on:
2020-01-03 2020-03-27
Flow-metering devices for connection to terminal units of
medical gas pipeline systems
AMENDMENT 2
Dispositifs de mesure de débit pour raccordement aux prises murales des systèmes de distribution de gaz
médicaux
AMENDEMENT 2
ICS: 11.040.10
THIS DOCUMENT IS A DRAFT CIRCULATED
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NOT BE REFERRED TO AS AN INTERNATIONAL
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ISO 15002:2008/DAM 2:2020(E)
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TO SUBMIT, WITH THEIR COMMENTS,
NOTIFICATION OF ANY RELEVANT PATENT
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PROVIDE SUPPORTING DOCUMENTATION. ISO 2020
ISO 15002:2008/DAM 2:2020(E)
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ISO 15002:2008/DAM 2:2020(E)
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