| ISO 5832-1 Fifth edition 2016-07-15 Implants for surgery - Metallic materials - Part 1: Wrought stainless steel |
| Recognition Date | 2016-12-23 |
| Recognition List | 046 |
| Recognition Number | 8-435 |
| Extent | Complete standard |
| Standards Orgs | ISO International Organization for Standardization https://www.iso.org/ |
| STG | Materials |
This standard is relevant to medical devices and is recognized on its scientific and technical merit and/or because it supports existing regulatory policies.
This part of ISO 5832 specifies the characteristics of, and corresponding test methods for, wrought stainless steel for use in the manufacture of surgical implants.
NOTE 1 The mechanical properties of a sample obtained from a finished product made of this alloy can differ from those specified in this part of ISO 5832.
NOTE 2 The alloy described in this part of ISO 5832 corresponds to UNS S31673 referred to in ASTM F138/ASTM F139 and to alloy code 1.4441 given in the withdrawn DIN 17443.
| Regulation Number | Device Name | Device Class | Product Code |
| Metallic components of all implantables | |||
| No product code information listed for §888.3XXX, Metallic components of all implantables | |||
| §872.5500 | Headgear, Extraoral, Orthodontic | Class 2 | DZB |
| §872.5410 | Band, Elastic, Orthodontic | Class 1 | ECI |
| §872.5410 | Band, Material, Orthodontic | Class 1 | DYO |
| §872.5410 | Band, Preformed, Orthodontic | Class 1 | ECM |
| §872.5410 | Clamp, Wire, Orthodontic | Class 1 | ECN |
| §872.5410 | Retainer, Screw Expansion, Orthodontic | Class 1 | DYJ |
| §872.5410 | Spring, Orthodontic | Class 1 | ECO |
| §872.5410 | Tube, Orthodontic | Class 1 | DZD |
| §872.5410 | Wire, Orthodontic | Class 1 | DZC |
| §872.4880 | Screw, Fixation, Intraosseous | Class 2 | DZL |
| §872.4760 | External Mandibular Fixator And/Or Distractor | Class 2 | MQN |
| §872.4760 | Implant, Transmandibular | Class 2 | MDL |
| §872.4760 | Plate, Bone | Class 2 | JEY |
| §872.4600 | Lock, Wire, And Ligature, Intraoral | Class 2 | DYX |
| §872.4565 | Accessories, Retractor, Dental | Class 1 | EIF |
| §872.4565 | Aligner, Bracket, Orthodontic | Class 1 | ECQ |
| §872.4565 | Broach, Endodontic | Class 1 | EKW |
| §872.4565 | Burnisher, Operative | Class 1 | EKJ |
| §872.4565 | Carrier, Amalgam, Operative | Class 1 | EKI |
| §872.4565 | Carver, Dental Amalgam, Operative | Class 1 | EKH |
| §872.4565 | Carver, Wax, Dental | Class 1 | EIK |
| §872.4565 | Chisel, Bone, Surgical | Class 1 | EML |
| §872.4565 | Chisel, Osteotome, Surgical | Class 1 | EMM |
| §872.4565 | Condenser, Amalgam And Foil, Operative | Class 1 | EKG |
| §872.4565 | Curette, Endodontic | Class 1 | EKT |
| §872.4565 | Curette, Operative | Class 1 | EKE |
| §872.4565 | Curette, Periodontic | Class 1 | EMS |
| §872.4565 | Curette, Surgical, Dental | Class 1 | EMK |
| §872.4565 | Driver, Band, Orthodontic | Class 1 | ECT |
| §872.4565 | Elevator, Surgical, Dental | Class 1 | EMJ |
| §872.4565 | Excavator, Dental, Operative | Class 1 | EKC |
| §872.4565 | Explorer, Operative | Class 1 | EKB |
| §872.4565 | File, Bone, Surgical | Class 1 | EMI |
| §872.4565 | File, Margin Finishing, Operative | Class 1 | EKA |
| §872.4565 | File, Pulp Canal, Endodontic | Class 1 | EKS |
| §872.4565 | Forceps, Articulation Paper | Class 1 | EFK |
| §872.4565 | Forceps, Dressing, Dental | Class 1 | EFL |
| §872.4565 | Forceps, Rongeur, Surgical | Class 1 | EMH |
| §872.4565 | Forceps, Tooth Extractor, Surgical | Class 1 | EMG |
| §872.4565 | Gauge, Depth, Instrument, Dental | Class 1 | EIL |
| §872.4565 | Handle, Instrument, Dental | Class 1 | EJB |
| §872.4565 | Hemostat, Surgical | Class 1 | EMD |
| §872.4565 | Hoe, Periodontic | Class 1 | EMQ |
| §872.4565 | Instrument, Contouring, Matrix, Operative | Class 1 | EKF |
| §872.4565 | Instrument, Cutting, Operative | Class 1 | EKD |
| §872.4565 | Instrument, Filling, Plastic, Dental | Class 1 | EIY |
| §872.4565 | Instrument, Hand, Calculus Removal | Class 1 | ELA |
| §872.4565 | Instrument, Ligature Tucking, Orthodontic | Class 1 | ECP |
| §872.4565 | Instruments, Dental Hand | Class 1 | DZN |
| §872.4565 | Knife, Margin Finishing, Operative | Class 1 | EJZ |
| §872.4565 | Knife, Periodontic | Class 1 | EMO |
| §872.4565 | Marker, Periodontic | Class 1 | EMP |
| §872.4565 | Mirror, Mouth | Class 1 | EAX |
| §872.4565 | Plier, Orthodontic | Class 1 | JEX |
| §872.4565 | Pliers, Operative | Class 1 | EJY |
| §872.4565 | Plugger, Root Canal, Endodontic | Class 1 | EKR |
| §872.4565 | Preparer, Root Canal Endodontic | Class 1 | EKQ |
| §872.4565 | Probe, Periodontic | Class 1 | EIX |
| §872.4565 | Punch, Biopsy, Surgical | Class 1 | EME |
| §872.4565 | Pusher, Band, Orthodontic | Class 1 | ECS |
| §872.4565 | Reamer, Pulp Canal, Endodontic | Class 1 | EKP |
| §872.4565 | Remover, Crown | Class 1 | EIS |
| §872.4565 | Retainer, Matrix | Class 1 | JEP |
| §872.4565 | Retractor, All Types | Class 1 | EIG |
| §872.4565 | Scaler, Periodontic | Class 1 | EMN |
| §872.4565 | Scissors, Collar And Crown | Class 1 | EIR |
| §872.4565 | Scissors, Surgical Tissue, Dental | Class 1 | EGN |
| §872.4565 | Setter, Band, Orthodontic | Class 1 | ECR |
| §872.4565 | Spreader, Pulp Canal Filling Material, Endodontic | Class 1 | EKK |
| §872.4565 | Syringe, Periodontic, Endodontic, Irrigating | Class 1 | EIC |
| §872.4565 | Syringe, Restorative And Impression Material | Class 1 | EID |
| §872.4565 | Unit, Syringe, Air And/Or Water | Class 1 | ECB |
| §872.4200 | Handpiece, Air-Powered, Dental | Class 1 | EFB |
| §872.4200 | Handpiece, Belt And/Or Gear Driven, Dental | Class 1 | EFA |
| §872.4200 | Handpiece, Contra- And Right-Angle Attachment, Dental | Class 1 | EGS |
| §872.4130 | Drill, Dental, Intraoral | Class 1 | DZA |
| §872.4120 | Drill, Bone, Powered | Class 2 | DZI |
| §872.4120 | Driver, Wire, And Bone Drill, Manual | Class 2 | DZJ |
| §872.4120 | Handpiece, Rotary Bone Cutting | Class 2 | KMW |
| §872.4120 | Saw, Bone, Ac-Powered | Class 2 | DZH |
| §872.3900 | Teeth, Artificial, Posterior With Metal Insert | Class 1 | ELJ |
| §872.3810 | Post, Root Canal | Class 1 | ELR |
| §872.3740 | Pin, Retentive And Splinting, And Accessory Instruments | Class 1 | EBL |
| §872.3580 | Teeth, Preformed Gold Denture | Class 1 | ELN |
| §872.3360 | Cusp, Preformed | Class 1 | EHQ |
| §872.3350 | Cusp, Gold And Stainless Steel | Class 1 | ELO |
| §872.3330 | Crown, Preformed | Class 1 | ELZ |
| §872.3285 | Clasp, Preformed | Class 1 | EHP |
| §872.3240 | Bur, Dental | Class 1 | EJL |
| §872.3165 | Attachment, Precision, All | Class 1 | EGG |
| §872.3130 | Anchor, Preformed | Class 1 | EJX |
| There is no relevant guidance developed at this time. |