This standard establishes labeling, safety, and performance requirements and referee tests for transcutaneous electrical stimulators (including TENS) intended for use in the treatment of pain syndrome. Also covered are labeling requirements for patient leads and electrodes.<\/p>\n
| PDF Pages<\/th>\n | PDF Title<\/th>\n<\/tr>\n | ||||||
|---|---|---|---|---|---|---|---|
| 1<\/td>\n | ANSI\/AAMI NS4:2013, Transcutaneous electrical nerve stimulators <\/td>\n<\/tr>\n | ||||||
| 2<\/td>\n | Objectives and uses of AAMI standards and recommended practices <\/td>\n<\/tr>\n | ||||||
| 3<\/td>\n | Title page <\/td>\n<\/tr>\n | ||||||
| 4<\/td>\n | AAMI Standard Copyright information <\/td>\n<\/tr>\n | ||||||
| 5<\/td>\n | Contents <\/td>\n<\/tr>\n | ||||||
| 7<\/td>\n | Glossary of equivalent standards <\/td>\n<\/tr>\n | ||||||
| 8<\/td>\n | Committee representation <\/td>\n<\/tr>\n | ||||||
| 9<\/td>\n | Foreword <\/td>\n<\/tr>\n | ||||||
| 11<\/td>\n | 1 Scope 1.1 General 1.2 Inclusions 1.3 Exclusions 2 Normative references 3 Requirements 3.1 Labeling Requirements 3.1.1 Device Markings <\/td>\n<\/tr>\n | ||||||
| 12<\/td>\n | 3.1.2 Clinician Information 3.1.2.1 Stimulus Generator <\/td>\n<\/tr>\n | ||||||
| 13<\/td>\n | 3.1.2.2 TENS Leads\/Electrodes 3.1.3 Patient Information 3.2 Safety and Performance Requirements for the Stimulus Generator 3.2.1 Electrical Safety 3.2.2 Output Characteristics 3.2.2.1 Efficacy Considerations <\/td>\n<\/tr>\n | ||||||
| 14<\/td>\n | 3.2.2.2 Safety Considerations 3.2.3 Functional Controls 3.2.4 Open\/Short Circuit Performance 3.2.5 Incorrect Battery Installation 3.2.6 Environmental Performance 4 Test Methods 4.1 Compliance with the Labeling Requirements 4.1.1 Device Markings 4.1.2 Clinician Information 4.1.3 Patient Information <\/td>\n<\/tr>\n | ||||||
| 15<\/td>\n | 4.2 Compliance with the Safety and Performance Requirements for the Stimulus Generator 4.2.1 Electrical Safety 4.2.2 Output Characteristics 4.2.3 Functional Controls 4.2.4 Open\/Short Circuit Performance 4.2.5 Incorrect Battery Installation 4.2.6 Environmental Performance 4.2.6.1 Temperature (Operating) <\/td>\n<\/tr>\n | ||||||
| 16<\/td>\n | 4.2.6.2 Humidity (Endurance) 4.2.6.3 Water Immersion 4.2.6.4 Solvent Resistance 4.2.6.5 Vibration (Operating) 4.2.6.6 Mechanical Shock (Non-Operating) 5 Glossary 5.1 Electrode system conductive medium 5.2 Lead 5.3 Pulse 5.4 Serial number 5.5 Stimulus generator 5.6 TENS <\/td>\n<\/tr>\n | ||||||
| 17<\/td>\n | Annex A – Labeling\/User Guidelines for Transcutaneous Electrical Nerve Stimulators (Contraindications, Warnings, Precautions) A.1 Introduction A.2 Contraindications A.3 Warnings A.4 Precautions <\/td>\n<\/tr>\n | ||||||
| 18<\/td>\n | Annex B – Development and Provisions of this Standard B.1 Introduction B.2 Need for the Standard <\/td>\n<\/tr>\n | ||||||
| 19<\/td>\n | B.3 Rationale for the Specific Provisions of the Standard B.3.1 Rationale for the Labeling Requirements B.3.1.1 Device Markings B.3.1.2 Clinician Information B.3.1.3 Patient Information B.3.2 Safety and Performance Requirements for the Stimulus Generator B.3.2.1 Electrical Safety B.3.2.2 Output Characteristics <\/td>\n<\/tr>\n | ||||||
| 21<\/td>\n | B.3.2.3 Functional Controls B.3.2.4 Open\/Short Circuit Performance <\/td>\n<\/tr>\n | ||||||
| 22<\/td>\n | B.3.2.5 Incorrect Battery Installation B.3.2.6 Environmental Performance B.4 Rationale for the Test Methods B.5 Rationale for Annex A. Labeling Guidelines <\/td>\n<\/tr>\n | ||||||
| 23<\/td>\n | Annex C – Bibliography <\/td>\n<\/tr>\n<\/table>\n","protected":false},"excerpt":{"rendered":" ANSI\/AAMI NS4:2013\/(R)2017 – Transcutaneous electrical nerve stimulators<\/b><\/p>\n |