AAMI RT2 pdf free download

AAMI RT2 pdf free download.Radiation therapy readiness check.
4 S AFETY and ESSENTIAL PERFORMANCE 4.1 Interfaces Information transfer between systems (particularly any between a TPS, TMS or TDS) that is compliant with this standard shall be in accordance with DICOM, as applicable. Where appropriate, use of the DICOM Unified Worklist in accordance with the IHE-RO TDW-II profile [1 7] is preferred, with documented demonstration of adherence by including an IHE Integration Statement in the ACCOMPANYING DOCUMENTS . 4.2 B ASIC SAFETY and ESSENTIAL PERFORMANCE 4.2.1 The MANUFACTURER shall conform with the normative clauses in ISO 1 4971 to ensure that a formal PROCESS is used to address general RISK MANAGEMENT aspects related to radiation therapy medical devices. 4.2.2 The MANUFACTURER shall comply with the requirements of IEC 60601 -1 :2005 + AMD 1 :201 2, IEC 60601 -2-1 :2009 + AMD1 :201 4, IEC 60601 -2-64:201 4, IEC 60601 -2-68:201 4, IEC 62083:2009 and IEC 62274:2005 that are applicable to the particular product in question. 4.2.3 This standard serves to identify additional PATIENT SAFETY features and it shall in no way substitute for, nor obviate any of, the BASIC SAFETY and ESSENTIAL PERFORMANCE requirements provided in the standards referenced in 4.2.2.4.2.4 The MANUFACTURER shall provide mitigations of identified HAZARDS so that no identified potential SINGLE FAULT CONDITION or USE ERROR shall result in a HAZARD that would be reasonably likely to cause death or serious injury, when a QUALIFIED PERSON uses the product as directed. Implicit in this understanding is that the RESPONSIBLE ORGANIZATION shall employ, at a minimum, industry-standard or peer- reviewed published consensus quality assurance measures appropriate for the treatments being planned and delivered. Examples of applicable peer-reviewed quality assurance measures include, but are not limited to the published reports from AAPM Task Groups 40 [8] , 53 [9] , 1 00 [1 0] and 1 42 [1 1 ] . 4.3 M ANUFACTURER provided compliance statement ( ACCOMPANYING DOCUMENTS ) 4.3.1 The MANUFACTURER claiming compliance with this standard for a given product shall include a statement of compliance in the ACCOMPANYING DOCUMENTS for that product, detailing the rationale for such claim(s). 4.3.2 Compliance statement(s) and reference to this standard may also be used as part of routine commercial promotion and as part of submissions to regulatory bodies. 4.3.3 Compliance statements should include a description of specific product features and how those features provide the capabilities described herein. If only certain sections of this standard are deemed to be applicable to a particular product, those sections should be clearly identified in the compliance statement contained in the ACCOMPANYING DOCUMENTS , along with rationale for the exclusion or non- applicability of the remaining sections.4.3.4 If compliance with any section of this standard, in a given situation, requires multiple products to be used in combination, the particulars shall be described in the ACCOMPANYING DOCUMENTS . (For example, the use of a TDD from one MANUFACTURER in combination with a TMS from another MANUFACTURER shall be described by both.) 4.3.5 Known limitations or issues affecting the clinical implementation of this standard, including those found in interfaces between devices, shall be described in the ACCOMPANYING DOCUMENTS . 4.3.6 Updates to the ACCOMPANYING DOCUMENTS shall be issued as deemed appropriate by the MANUFACTURER but shall at least accompany major new releases. 4.3.7 If any features that may be deemed by the MANUFACTURER to be a preferred implementation of this standard are offered as optional features (i.e., provided at additional cost) or are otherwise separately purchasable (e.g., available as a field upgrade to pre-existing units), then a list of such optional features shall be clearly provided in the compliance statement contained in the ACCOMPANYING DOCUMENTS for the affected product(s).AAMI RT2  pdf download.