Safety and performance standards
All medical supplies and equipment should meet international, regional or national safety and performance standards. The most important standards include:
IEC – which are international standards for the electrical safety of electrical and electromechanical equipment,and apply to refrigerators for example. IEC 601 is the international standard specifically for electrical and mechanically safe medical equipment for use by staff and with patients.
ISO – which are international standards for quality management and systems. ISO 9000–9004 is a series of standards covering the quality of manufacturing processes, design and development, construction, installation and service. ISO standards do not currently exist for all medical supplies and equipment, but do apply to syringes, needles, gloves, instruments and scales, for example.
CE mark – which indicates that a product meets European Union directive standards, and apply to sterile medical supplies for example.
Pharmacopoeia specifications – which establish quality specifications for the most commonly used drugs and some medical supplies, such as bandages, tape and swabs. Important pharmacopoeias include the British (BP), European (EP), United States (USP) and WHO International Pharmacopoeia (IP).
Quality certificates or export certificates – which are issued under various national and regional standards
such as ISO 9000 or the equivalent EN 29000.
All medical supplies and equipment should meet international, regional or national safety and performance standards. The most important standards include:
IEC – which are international standards for the electrical safety of electrical and electromechanical equipment,and apply to refrigerators for example. IEC 601 is the international standard specifically for electrical and mechanically safe medical equipment for use by staff and with patients.
ISO – which are international standards for quality management and systems. ISO 9000–9004 is a series of standards covering the quality of manufacturing processes, design and development, construction, installation and service. ISO standards do not currently exist for all medical supplies and equipment, but do apply to syringes, needles, gloves, instruments and scales, for example.
CE mark – which indicates that a product meets European Union directive standards, and apply to sterile medical supplies for example.
Pharmacopoeia specifications – which establish quality specifications for the most commonly used drugs and some medical supplies, such as bandages, tape and swabs. Important pharmacopoeias include the British (BP), European (EP), United States (USP) and WHO International Pharmacopoeia (IP).
Quality certificates or export certificates – which are issued under various national and regional standards
such as ISO 9000 or the equivalent EN 29000.
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