The International Organization for Standardization (ISO) has several schedules that hospitals follow in order to maintain their ISO certification. The standards cover surgical gloves, medical gloves and even the wheels used on hospital beds. All ISO standards for hospitals are updated regularly and outline the pinnacle of hospital performance and safety standards for the benefit of patients, families and health care professionals alike.
ISO 10282: 2002 details packaging and storage requirements for surgical gloves. The goal of the standard is to prevent cross-contamination between patients, health care professionals and gloves. ISO intends this standard to be a performance and safety guide concerning rubber gloves. The standard applies to single-use gloves, but does not apply to examination or procedure gloves.
ISO 11193: 2008 pertains to hospital gloves that a health care professional would use in handling contaminated medical materials. ISO 11193:2008 has two sections and concerns the bulk storage and packaging requirements for non-surgical gloves; it does not cover the safe and proper usage of examination gloves.
Part one concerns packaging and bulk storage while part two concerns gloves intended for use in diagnostic or therapeutic procedures with the goal of protecting patients from cross-contamination.
Powdered Rubber Medical Gloves
ISO 21171:2006 describes standards for the presence of removable powder on the surface of medical gloves. There are three methods: Method A pertains to powdered gloves and Methods B and C for powder-free gloves. The standard does not address safety issues that may be associated with powdered gloves, nor does it prescribe limits on the amounts that may be present.
Medical Face-Mask Quality
ISO 22609:2004 addresses a laboratory testing method which measures how effectively medical face masks resist penetration by a splash of synthetic blood. The standard primarily concerns the performance of materials from which the masks are manufactured and does not address the mask's design, construction, interfaces or other factors which may affect the overall protection.
Castors and Wheels on Hospital Beds
ISO 22882: 2004 specifies technical requirements and dimensions for wheels and locking mechanisms on hospital beds. The standard addresses swivel-type castors and wheels that have a dimension of 100mm or more. Nine countries adhere to this standard, most of them in Europe; an additional 12 countries acknowledge the standard's validity.
Hospital Bed Performance
ISO 60601:2009 addresses the basic function, performance and safety features of many hospital beds. The standard comes in two sections, the first of which replaced an earlier standard. ISO 60601 applies only to beds that are intended for adults and focuses on modernising existing safety benchmarks. The first section of ISO 60601 was updated in 2010 and covers electrical equipment associated with hospital beds; the second section was updated in 2009 and covers the safety of the bed apparatus itself.
Heating Pads and Blankets
ISO 80601: 2009 covers safety concerns related to heating pads, blankets and other electrical bedding used on pedeatric patients. The standard establishes safety parameters which minimise health risks to patients and health care professionals, as well as specific tests for the devices. ISO 80601: 2009 updates the 1996 version of the same standard.
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