家庭環(huán)境下使用的醫(yī)療設(shè)備檢測

家庭環(huán)境下使用的醫(yī)療設(shè)備檢測項(xiàng)目報(bào)價(jià)？??解決方案？??檢測周期？??樣品要求？

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YY 0784-2010醫(yī)用電氣設(shè)備 醫(yī)用脈搏血氧儀設(shè)備基本安全和主要性能專用要求

引用GB 9706.1-2007的第1章,不包括以下內(nèi)容。 修改(增加在1.1末尾處) 本標(biāo)準(zhǔn)詳細(xì)描述了適用于人體使用的脈搏血氧儀設(shè)備的基本安全和主要性能的專用要求,該設(shè)備包括在正常使用中的任何必要的部件,如脈搏血氧監(jiān)護(hù)儀、脈搏血氧探頭、探頭電纜延長線等。 這些要求也適用于經(jīng)再加工的脈搏血氧儀設(shè)備,包括脈搏血氧監(jiān)護(hù)儀,血氧探頭和探頭電纜延長線等。 脈搏血氧儀設(shè)備的應(yīng)用范圍包括,而不僅限于,在醫(yī)療保健機(jī)構(gòu)和家庭中估計(jì)患者的動脈血氧飽和度和脈率。 本標(biāo)準(zhǔn)不適用于實(shí)驗(yàn)室研究使用的脈搏血氧儀設(shè)備,也不適用于需采集患者血液樣本的血氧儀。 本標(biāo)準(zhǔn)不適用于胎兒專用脈搏血氧儀設(shè)備。 本標(biāo)準(zhǔn)不適用于放置于患者環(huán)境之外顯示SpO<下標(biāo) 2>數(shù)值的遙測或主(從)設(shè)備。 本標(biāo)準(zhǔn)的要求替代或修改了GB 9706.1-2007,并預(yù)期優(yōu)先于相應(yīng)的通用要求。

DIN CEN ISO/TR 12296-2013人類工效學(xué). 醫(yī)療保健行業(yè)人員的人工操作 (ISO/TR 12296-2012); 德文版本CEN ISO/TR 12296-2013

The technical report DIN CEN ISO/TR 12296 provides guidance for assessing the problems and risks associated with manual patient handling in the healthcare sector, and for identifying and applying ergonomic strategies and solutions to those problems and risks. Its main goals are - to improve caregivers' working conditions by decreasing biomechanical overload risk, thus limiting work-related illness and injury, as well as the consequent costs and absenteeism, and - to account for patients' care quality, safety, dignity and privacy as regards their needs, including specific personal care and hygiene. It is intended for all users (or caregivers and workers) involved in healthcare manual handling and, in particular, healthcare managers and workers, occupational safety and health caregivers, producers of assistive devices and equipment, education and training supervisors, and designers of healthcare facilities. Its recommendations are primarily applicable to the movement of people (adults and children) in the provision of healthcare services in purposely built or adapted buildings and environments. Some recommendations can also be applied to wider areas (e. g. home care, emergency care, voluntary caregivers, cadaver handling). The recommendations for patient handling take into consideration work organization, type and number of patients to be handled, aids, spaces where patients are handled, as well as caregivers' education and awkward postures, but do not apply to object (movement, transfer, pushing and pulling) or animal handling. Task joint analysis in a daily shift involving patient handling, pulling and pushing or object handling and transport is not considered.

DIN EN ISO 11073-00103-2017健康信息學(xué). 個(gè)人保健裝置通信. 第00103部分: 綜述(ISO/IEEE 11073-00103-2015); 英文版本EN ISO 11073-00103-2017

Within the context of the ISO/IEEE 11073 family of standards for device communication, this guide describes the landscape of transport-independent applications and information profiles for personal telehealth devices. These profiles define data exchange, data representation, and terminology for communication between personal health devices and compute engines (e. g., health appliances, set top boxes, cell phones, and personal computers). The guide provides a definition of personal telehealth devices as devices used for life activity, wellness monitoring, and/or health monitoring in domestic home, communal home, and/or mobile applications as well as professional medical usage. Use cases relevant to these scenarios and environments are also presented.

BS EN ISO 18778-2009呼吸設(shè)備.嬰兒監(jiān)視器.詳細(xì)要求(ISO 18778-2005)

IEC 60601-1:1988, Clause 1, applies except as follows:Amendments (add at end of 1.1):1.1This International Standard specifies requirements for the safety and essential performance of monitors used to detect apparent life-threatening events1) in sleeping or resting children under three years of age. This International Standard applies to devices used in home care applications. These monitors are generally used without continual professional supervision.This International Standard also applies to the accessories, e.g. probes and cables necessary to apply the monitor to the patient.This International Standard does not apply to monitors intended for use in health care facilities/institutions.The requirements of this International Standard, which replace or modify the requirements ofIEC 60601-1:1988 and its Amendments 1 (1991) and 2 (1995), are intended to take precedence over thecorresponding general requirements.1.4Addition:NOTE Planning and design of products complying with this Standard can have environmental impact during the product life cycle. Environmental aspects are addressed in Annex BB. Additional aspects of environmental impact are addressed in ISO 14971.