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1. WO1996004936 - INSTRUMENT STERILIZATION LIFE-SPAN INDICATOR

Publication Number WO/1996/004936
Publication Date 22.02.1996
International Application No. PCT/US1995/010445
International Filing Date 16.08.1995
Chapter 2 Demand Filed 16.02.1996
IPC
A61L 2/28 2006.01
AHUMAN NECESSITIES
61MEDICAL OR VETERINARY SCIENCE; HYGIENE
LMETHODS OR APPARATUS FOR STERILISING MATERIALS OR OBJECTS IN GENERAL; DISINFECTION, STERILISATION, OR DEODORISATION OF AIR; CHEMICAL ASPECTS OF BANDAGES, DRESSINGS, ABSORBENT PADS, OR SURGICAL ARTICLES; MATERIALS FOR BANDAGES, DRESSINGS, ABSORBENT PADS, OR SURGICAL ARTICLES
2Methods or apparatus for disinfecting or sterilising materials or objects other than foodstuffs or contact lenses; Accessories therefor
26Accessories
28Devices for testing the effectiveness or completeness of sterilisation, e.g. indicators which change colour
A61L 29/14 2006.01
AHUMAN NECESSITIES
61MEDICAL OR VETERINARY SCIENCE; HYGIENE
LMETHODS OR APPARATUS FOR STERILISING MATERIALS OR OBJECTS IN GENERAL; DISINFECTION, STERILISATION, OR DEODORISATION OF AIR; CHEMICAL ASPECTS OF BANDAGES, DRESSINGS, ABSORBENT PADS, OR SURGICAL ARTICLES; MATERIALS FOR BANDAGES, DRESSINGS, ABSORBENT PADS, OR SURGICAL ARTICLES
29Materials for catheters or for coating catheters
14Materials characterised by their function or physical properties
A61L 31/14 2006.01
AHUMAN NECESSITIES
61MEDICAL OR VETERINARY SCIENCE; HYGIENE
LMETHODS OR APPARATUS FOR STERILISING MATERIALS OR OBJECTS IN GENERAL; DISINFECTION, STERILISATION, OR DEODORISATION OF AIR; CHEMICAL ASPECTS OF BANDAGES, DRESSINGS, ABSORBENT PADS, OR SURGICAL ARTICLES; MATERIALS FOR BANDAGES, DRESSINGS, ABSORBENT PADS, OR SURGICAL ARTICLES
31Materials for other surgical articles
14Materials characterised by their function or physical properties
G01N 31/22 2006.01
GPHYSICS
01MEASURING; TESTING
NINVESTIGATING OR ANALYSING MATERIALS BY DETERMINING THEIR CHEMICAL OR PHYSICAL PROPERTIES
31Investigating or analysing non-biological materials by the use of the chemical methods specified in the subgroups; Apparatus specially adapted for such methods
22using chemical indicators
CPC
A61B 2090/0814
AHUMAN NECESSITIES
61MEDICAL OR VETERINARY SCIENCE; HYGIENE
BDIAGNOSIS; SURGERY; IDENTIFICATION
90Instruments, implements or accessories specially adapted for surgery or diagnosis and not covered by any of the groups A61B1/00 - A61B50/00, e.g. for luxation treatment or for protecting wound edges
08Accessories or related features not otherwise provided for
0814Preventing re-use
A61L 2/28
AHUMAN NECESSITIES
61MEDICAL OR VETERINARY SCIENCE; HYGIENE
LMETHODS OR APPARATUS FOR STERILISING MATERIALS OR OBJECTS IN GENERAL; DISINFECTION, STERILISATION, OR DEODORISATION OF AIR; CHEMICAL ASPECTS OF BANDAGES, DRESSINGS, ABSORBENT PADS, OR SURGICAL ARTICLES; MATERIALS FOR BANDAGES, DRESSINGS, ABSORBENT PADS, OR SURGICAL ARTICLES
2Methods or apparatus for disinfecting or sterilising materials or objects other than foodstuffs or contact lenses; Accessories therefor
26Accessories ; or devices or components used for biocidal treatment
28Devices for testing the effectiveness or completeness of sterilisation, e.g. indicators which change colour
A61L 29/14
AHUMAN NECESSITIES
61MEDICAL OR VETERINARY SCIENCE; HYGIENE
LMETHODS OR APPARATUS FOR STERILISING MATERIALS OR OBJECTS IN GENERAL; DISINFECTION, STERILISATION, OR DEODORISATION OF AIR; CHEMICAL ASPECTS OF BANDAGES, DRESSINGS, ABSORBENT PADS, OR SURGICAL ARTICLES; MATERIALS FOR BANDAGES, DRESSINGS, ABSORBENT PADS, OR SURGICAL ARTICLES
29Materials for catheters, ; medical tubing, cannulae, or endoscopes; or for coating catheters
14Materials characterised by their function or physical properties ; , e.g. lubricating compositions
A61L 31/14
AHUMAN NECESSITIES
61MEDICAL OR VETERINARY SCIENCE; HYGIENE
LMETHODS OR APPARATUS FOR STERILISING MATERIALS OR OBJECTS IN GENERAL; DISINFECTION, STERILISATION, OR DEODORISATION OF AIR; CHEMICAL ASPECTS OF BANDAGES, DRESSINGS, ABSORBENT PADS, OR SURGICAL ARTICLES; MATERIALS FOR BANDAGES, DRESSINGS, ABSORBENT PADS, OR SURGICAL ARTICLES
31Materials for other surgical articles ; , e.g. stents, stent-grafts, shunts, surgical drapes, guide wires, materials for adhesion prevention, occluding devices, surgical gloves, tissue fixation devices
14Materials characterised by their function or physical properties ; , e.g. injectable or lubricating compositions, shape-memory materials, surface modified materials
G01N 31/226
GPHYSICS
01MEASURING; TESTING
NINVESTIGATING OR ANALYSING MATERIALS BY DETERMINING THEIR CHEMICAL OR PHYSICAL PROPERTIES
31Investigating or analysing non-biological materials by the use of the chemical methods specified in the subgroup
22using chemical indicators
226for investigating the degree of sterilisation
Applicants
  • STERIS CORPORATION [US/US]; 5960 Heisley Road Mentor, OH 44060, US
Inventors
  • MALCHESKY, Paul, S.; US
  • GRIGNOL, George, E.; US
Agents
  • KOCOVSKY, Thomas, E., Jr.; Fay, Sharpe, Beall, Fagan, Minnich & McKee Suite 700 1100 Superior Avenue Cleveland, OH 44114-2518, US
Priority Data
08/291,98917.08.1994US
Publication Language English (EN)
Filing Language English (EN)
Designated States
Title
(EN) INSTRUMENT STERILIZATION LIFE-SPAN INDICATOR
(FR) INDICATEUR DE DUREE DE VALIDITE DE STERILISATION D'INSTRUMENTS
Abstract
(EN)
A pigment such as crystal violet is impregnated in or otherwise affixed to a translucent plastic or porous member (14, 22). The color change material changes at least one of opacity or color with repeated exposure to a fluid sterilant, such as an oxidant solution. A label (10, 24) is mounted behind the translucent plastic material and carries an indicia (12, 26). With repeated sterilizations of the instrument, the color change material becomes progressively more translucent, allowing the indicia to be read through the translucent plastic material. When the indicia becomes visible, such as after about 7 sterilization cycles in Figure 3, the user is warned to discontinue use of the instrument, either discarding it or having it rebuilt. Rather than having a written indicia, a color scale (30) can be provided for comparison against the current color of the color change material. When the color changes to the discard color on the color scale, the user is again advised to discontinue use of or rebuild the instrument.
(FR)
Un pigment, tel que du violet de méthyle, est amené à imprégner ou est fixé autrement à un élément en matière plastique translucide ou poreuse (14, 22). La substance à coloration changeante modifie soit l'opacité soit la couleur sous l'effet d'une exposition répétée à un agent stérilisateur fluide, tel qu'une solution oxydante. Une étiquette (10, 24) est placée derrière la matière plastique translucide et comporte une marque (12, 26). Au fil des stérilisations répétées de l'instrument, la matière à coloration changeante devient progressivement plus translucide, permettant de lire la marque à travers cette matière plastique translucide. Lorsque la marque devient visible, comme après environ sept cycles de stérilisation (figure 3), l'utilisateur est averti qu'il ne doit plus utiliser l'instrument, et donc qu'il doit soit le jeter soit le faire remettre en état. Plutôt que de recourir à une marque faite de caractères d'écriture, une échelle de couleurs (30) permet une comparaison par rapport à la couleur habituelle de la matière à coloration changeante. Lorsque la couleur vire à la couleur d'alerte, l'utilisateur est averti qu'il doit cesser d'utiliser l'instrument ou le faire remettre en état.
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