Quality Management 2017

Value driven tolerance limits – RP162 The suspension levels identified have varying degrees of authority and consensus attaching to them. These are represented by g oupi g them under the headings A to D in order of preference (Table 1-4).

Table 1-4 Types of Suspension Level

Suspension Level

Definition

Type A

This is based on an international standard or a formal international or national regulation. This is based on formal recommendations by scientific, medical or professional bodies. This is based on material published in well-established peer reviewed scientific or medical journals and/or (exceptionally) based on reviewed recommendations from the drafting group. For Types A/C and B/C, see the text. The need for a Type D suspension level arises when it has not been possible to make recommendations for explicit suspension levels (see text).

Type B

Type C

Type D

“Failure to meet a suspension level will establish that the operation of the equipment

involved is sufficiently poor to raise an alarm indicating action is required”

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SUSPENSION LEVEL = ACTION LIMIT

Criteria for Acceptability of Medical Radiological Equipment used in Diagnostic Radiology, Nuclear Medicine

and Radiotherapy. RP 162 (European Commission), 2013