Current standards on health and medical technology
Healthy and happy
Ideally, we would all be healthy at all times. But diseases and injuries form part of life. To cure or heal them, medical science has found effective methods and means and constantly improves them.
Alongside European and national legislation, numerous standards aim at assuring quality. Thereby, products of medical technology and management methods can be optimised. Austria plays a pioneering role in medical standardisation.
- Credit: ASI prm
One language for all
In Austria, more than 500 standards relate to health and medical technology in their broadest sense. Several international, European and national standards draw up the basic foundation in this field. They answer questions such as “What is the meaning of specific terms?” and “Which symbols have to be used?”
Health and medical technology (examples):
ÖNORM EN 980: Symbols for use in the labelling of medical devices
ÖNORM EN ISO 3826-2: Plastics collapsible containers for human blood and blood components - Graphical symbols for use on labels and instruction leaflets
ÖNORM EN 1041: Information supplied by the manufacturer with medical devices
ÖNORM K 1910: Terminology in the field of healthcare - Terms and definitions
- Credit: ASI prm
From syringes to anaesthetic machines
Beyond terminology and symbols, standards deal with products that come into contact with the human body. The EU’s Medical Devices Directive 93/42/EEC defines the basic framework. Be it syringes, gloves, hoses fitted to devices or catheters, the specifications define the requirements to be met by these products.
Medical products (examples):
ÖNORM EN 27740: Instruments for surgery - Scalpels with detachable blades, fitting dimensions
ÖNORM EN ISO 7864: Sterile hypodermic needles for single use
ÖNORM EN ISO 7886: Sterile hypodermic syringes for single use
ÖNORM EN 455: Medical gloves
ÖNORM EN ISO 26782: Anaesthetic and respiratory equipment - Spirometers
- Credit: ASI prm
Clean and sterile
During medical check-ups and surgical interventions, hygienic work practices are of utmost importance. Devices, forceps, scissors and implants have to be sterile. The related requirements and test methods are laid down in European standards.
Sterilisation (examples):
ÖNORM EN 556-2: Aseptically processed medical devices
ÖNORM EN 14180: Low temperature steam and formaldehyde sterilizers
ÖNORM EN 12791: Surgical hand disinfection
ÖNORM EN 285: Steam sterilizers - Large sterilizers
- Credit: ASI prm
Health can be managed
In addition to the products’ functionalities, health standardisers have turned to a new field of work in recent years: quality management. Pioneered in the business world, it now gains ground in the medical world. Experts elaborate special management standards tailored to the needs of medicine. Practice-tested systems serve well in sterilisation, packaging and the production of medical devices.
Quality management (examples):
ÖNORM EN ISO 13485: Medical devices - Quality management systems - Requirements for regulatory purposes
ÖNORM EN ISO 17665-1: Sterilization of health care products - Requirements for the development, validation and routine control of a sterilization process for medical devices
ÖNORM EN ISO 15378: Primary packaging materials for medicinal products - Particular requirements for the application of ISO 9001:2000, with reference to Good Manufacturing Practice (GMP)
ÖNORM EN ISO 14971: Medical devices - Application of risk management to medical devices
- Credit: ASI prm
Practice tests in nursing
Austrian experts are highly active in European and international standardisation. The trend clearly goes away from national specifications. However, Austria has tested quality standards in nursing for more than eight years. Thereby, the country has broken new ground. In line with the Austrian Nursing Act, the well-proven rules will become standards.
ON Rules on quality management in nursing
ONR 116001: Nursing assessment within the framework of the care process
ONR 116007: Nursing diagnosis in the frame of the care process
ONR 116008: Nursing care planning - Goal establishment and care interventions in the frame of the care process
ONR 116009: Care interventions in the frame of the care process
ONR 116010: Evaluation of the effectiveness of patient care
- Credit: pixelio.de
Outlook
In addition to technical standards on medical devices, the experts look further into the world of practical work. Medicine and health can be managed, quality demands of nursing services become transparent and traceable based on standards.
With the help of standardisation, the risks inseparably linked with medicine can be tackled. The tools of risk management - laid down in the ON Rule series ONR 49000 - are increasingly introduced into the management systems of hospitals and clinics. Austrian Standards plus Trainings offers, for example, special courses for clinical risk managers.
